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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000502-11 | EudraCT Number |
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| Name | Class |
|---|---|
| EKOS Corporation | INDUSTRY |
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The objective is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure (together defined as the APT Procedure) as a treatment for acute submassive pulmonary embolism (PE). Symptomatic submassive PE are participants with acute (less than or equal to [≤]14 days) PE with normal systemic arterial blood pressure (greater than [>] 90 mmHg) and evidence of RV dysfunction (right ventricular to left ventricular diameter ratio, that is; RV/LV ratio greater than or equal to [≥] 0.9). Participants with submassive PE will be randomized to one of four APT treatment groups: ultrasound of 2 and 6 hours (hrs) with r-tPA 2 milligrams (mg)/hr/catheter and ultrasound 4 and 6 hours with r-tPA, 1 mg/hr/catheter. On 08 June 2016, randomization into treatment group 4 (APT/6 hours-r-tPA/2 mg/hr/catheter) was closed following a reported intracranial hemorrhage (ICH) and death in a study participant in this arm.
This study is designed to investigate the lowest recombinant tissue plasminogen activator (r-tPA) dose-ultrasound treatment time required to achieve the same reductions in thrombus burden and associated improvement in physiologic parameters demonstrated in ULTIMA (EKOS 08 [NCT01166997]) and SEATTLE II (EKOS 09 [NCT01513759]). Results of this study are intended to inform the study design for further studies of the Acoustic Pulse Thrombolysis (APT) Procedure. Analysis of the first 100 evaluable participants in the United States study suggested a degree of equipoise between treatment groups 1, 2 and 3 of the protocol and therefore the sample size has been extended and additional sites in the United Kingdom (UK) National Health Service included, with a view to adding to the findings of the OPTALYSE study from sites in the UK and increasing the number of participants treated by treatment protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APT/2 Hours-r-tPA/2 mg/hr/Catheter | Experimental | A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs. |
|
| APT/4 Hours-r-tPA/1 mg/hr/Catheter | Experimental | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. |
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| APT/6 Hours-r-tPA/1 mg/hr/Catheter | Experimental | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. |
|
| APT/6 Hours-r-tPA/2 mg/hr/Catheter | Experimental | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ekosonic® Endovascular Device ultrasonic infusion catheter | Device | r-tPA will be administered via EKOS. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio to 48 ± 6 Hours After the Start of the APT Procedure | Change from baseline in RV/LV will be determined by computed tomographic angiography (CTA). | Change from Baseline to 48 hrs ± 6 hours |
| Number of Participants With Major Bleeding Within 72 Hours After Initiating the APT Procedure | Criteria for major bleeding events, as defined by the International Society on Thrombosis and Haemostasis (ISTH): 1. Fatal bleeding and/or; 2. Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome) and/or; 3. Bleeding causing a fall in hemoglobin level of 20 grams/liter (g/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells. | Day 3 (within 72 hours after initiating the APT procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Success of an APT Procedure | Treatment success of an APT procedure will be assessed by an Adjudication Committee that is blinded to the participant's treatment. The criteria for treatment success are defined as follows: A decrease in RV/LV from baseline to 48 hours after the start of the procedure of at least 0.2; and no life-threatening adverse events related to PE or its treatment through 30 days after the start of the APT procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Tapson, MD | Cedar Sinai, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai | Beverly Hills | California | 90211 | United States | ||
| Tallahassee Memorial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32757658 | Background | Piazza G, Sterling KM, Tapson VF, Ouriel K, Sharp ASP, Liu PY, Goldhaber SZ. One-Year Echocardiographic, Functional, and Quality of Life Outcomes After Ultrasound-Facilitated Catheter-Based Fibrinolysis for Pulmonary Embolism. Circ Cardiovasc Interv. 2020 Aug;13(8):e009012. doi: 10.1161/CIRCINTERVENTIONS.120.009012. Epub 2020 Aug 6. | |
| 30025734 |
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A total of 131 subjects were randomized (ITT population) and 129 were treated (safety population). Two subjects were randomized into the trial but were not treated. One subject was randomized but prior to initiation of therapy, it was discovered the subject had chronic PE and was ineligible. One subject was randomized but decompensated prior to the initiation of therapy and expired. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4.
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| ID | Title | Description |
|---|---|---|
| FG000 | APT/2 Hours-r-tPA/2 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 15, 2019 | Jan 7, 2021 |
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| Recombinant tissue plasminogen activator | Biological | Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
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| From Baseline up to Day 30 |
| Change From Baseline in RV/LV at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph. | An echocardiogram was obtained at specified timepoints to evaluate RV/LV. | Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days) |
| Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph | The extent of displacement of the tricuspid valves, termed as TAPSE was measured at specified timepoints using echocardiogram. | Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days) |
| Change From Baseline in Estimated Right Ventricular Systolic Pressure (RVSP) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph | RVSP was measured at specified timepoints using echocardiogram. | Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days) |
| Percentage of Participants With Collapse of the Inferior Vena Cava (IVC) With Respiration at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph | The collapse of IVC was measured at specified timepoints using echocardiogram. | Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days) |
| Change From Baseline in Thrombus Burden by Miller Score as Assessed by Pulmonary Arteriogram (PAgram) at Day 0 | Miller score is composed of a score for arterial obstruction (objective score) and a score for reduction of peripheral perfusion of lungs (subjective evaluation). Right pulmonary artery (PA) is assigned 9 segmental arteries (3 to the upper, 2 to the middle, and 4 to the lower lobe), and left PA is assigned only 7 segmental arteries (2 to the upper, 2 to the lingula, and 3 to the lower lobe). Presence of segmental emboli, regardless of the degree of obstruction, is scored 1 point. Proximal emboli to the segmental level are scored a value equal to the number of segmental arteries arising distally. Maximal score of obstruction=16. Reduction of peripheral perfusion is scored by dividing each lung into upper, middle, and lower zones and by using a 4-point scale: 0=normal perfusion; 1=moderately reduced perfusion; 2=severely reduced perfusion; 3=no perfusion. Maximal score of reduced perfusion=18. Thus, the maximal Miller score =34. Higher Miller score=more thrombus burden. | Baseline, Day 0 (within 4 hours after APT end) |
| Change From Baseline in Thrombus Burden by Modified Miller Score as Assessed by CTA Scan at 48 ± 6 Hours After the Start of the APT Procedure | Modified miller score quantifies thrombus burden on CTA scans. Each segmental pulmonary artery (9 on the right, 7 on the left) that is fully or partly occluded by thrombus is given a score of 1. Any further proximal involves vessels score the number of segmental branches distal to that vessel, thereby giving a modified miller score of 0 (no thrombus) to 16 (thrombus in all segmental arteries or saddle embolism). | From Baseline to 48 hrs ± 6 hours |
| Change in 6 Minute Walk (6MW) Distance From Day 30 to Day 90 and 365 | The 6 minute Walk Test is a measure of functional exercise capacity. Participants will be asked to walk as far as possible within a 6-minute period, and the distance covered at the end will be noted and recorded. | Days 30, 90, 365 |
| Change in Borg Scale Score Before and After 6MW Distance Test at Days 30, 90, and 365 | Borg is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) and fatigue experienced before and after the 6MW distance test. Scores ranges from 0 (for no shortness of breath, or no fatigue) to 10 (for the greatest shortness of breath ever experienced, or maximum amount of fatigue felt). Higher scores indicates worse outcome. | Days 30, 90, and 365 |
| Number of Participants Who Received Oxygen Therapy | Oxygen source is categorized as room air, nasal prongs, mask, and intubated. | Days 30, 90, and 365 |
| Change in Participant Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) 6b Score From Day 30 to Day 365 | PROMIS-PF 6b questionnaire is developed by including 2-items from item-improved Health Assessment Questionnaire (HAQ) and 4-items from item-improved Physical Function-10 (PF-10) instruments. Both of these instruments assess participant's present abilities. Both "Item-Improved instruments" have 5-response options: HAQ - 1="without any difficulty," 2="with a little difficulty," 3="with some difficulty," 4="with much difficulty," 5="unable to do"; PF-10 - 1="not at all," 2="very little," 3="somewhat," 4="quite a lot," 5="cannot do." Total score is the average of all scores of component items, which ranges from 0 (no disability) to 100 (worst disability). | Day 30, Day 365 |
| Change in Pulmonary Embolism Quality of Life (PEmb-QOL) Score From Day 30 to Day 365 | The PEmb-QoL questionnaire contains 6 dimensions that has been created based on the contents of the items, frequency of complaints (Question [Q]1; score range: 1 [every day] to 5 [never]), activities of daily living (ADL) limitations (Q4; score range: 1 [limited a lot] to 3 [not at all]), work-related problems (Q5; response: yes/no), social limitations (Q6; score range: 1 [not at all] to 5 [extremely]), intensity of complaints (Q7 [pain in chest/shoulders]/8 [breathlessness]; score range: 1 [none] to 6 [very serious]) and emotional complaints (Q9; score range: 1 [at all times] to 6 [none of the times]). Total Score for all dimensions are calculated by the sum of the scores for each item of the dimension divided by the number of items. Total score ranges from 1 (better quality of life) to 100 (worst quality of life). Higher scores indicate poorer outcome (decreased quality of life). Questions 1, 4, 5, and 9 are reverse scored. Questions 2 and 3 provide descriptive information. | Day 30, Day 365 |
| Number of Participants Who Encountered Technical Procedural Complications | Technical complications associated with the use of the EKOS device will be recorded during catheter placement in the pulmonary artery and during the infusion procedure. | From device placement through Day 2 |
| Number of Participants With Symptomatic Recurrent Pulmonary Embolism (Per Adjudication) | Number of participants with symptomatic recurrent pulmonary embolism up to 365 days following the APT procedure, were reported. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | From Baseline up to Day 365 |
| Number of Participants Who Die Due to Any Cause | Number of participants who died due to any cause for up to 365 days following the APT procedure, were reported. | From Baseline up to Day 365 |
| For Participants of UK Sites: Freedom From Major Harm Occurring Between Enrolment and 30 Days | Number of UK participants with freedom from major harms assessed by Safety Monitor using the following criteria: 1) Mortality - all cause and PE related; 2) Cardiovascular (CV) collapse defined as one or more of the following: a) Greater than (>) 40 millimeters of mercury (mmHg) drop in systolic blood pressure (SBP) (for >15 minutes from documented blood pressure as an in-patient) despite intravenous (IV) fluid challenge and absence of new atrial arrhythmia; b) Requirement for emergency systemic thrombolysis; c) Requirement for emergency surgical embolectomy ; d) Requirement for vasopressors; e)and/or Intubation/Ventilation; 3) Major bleeding per ISTH; 4) Recurrent PE (confirmed by imaging); and/or 5) Surgical correction of device related complication. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Baseline up to Day 30 |
| For Participants of UK Sites:Change in EuroQual - 5 Dimensions - 5 Levels (EQ-5D-5L) Score From Day 30 to Day 365 | The EQ-5D-5L consists of 2 parts - the descriptive system (Index Score) and the EQ Visual Analogue scale (VAS Score). The EQ-5D-5L descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Each one digit number expressing the level selected for each dimension is combined into a 5-digit number describing the respondent's heath state. These 5-digit numbers are converted into an index value, where 1 represents full health and 0 is equivalent to death. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale with 100 being the best health imaginable and 0 being the worst health imaginable. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | Day 30, Day 365 |
| For Participants of UK Sites: Time From Hospital Admission to Diagnosis of PE | Duration of time between hospital admission and the diagnosis of pulmonary embolism (PE) measured in hours for UK participants.Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Baseline through Day 3 |
| For Participants of UK Sites: Time From Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for PE | Duration of time between Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for pulmonary embolism (PE) measured in hours for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Baseline through Day 3 |
| For Participants of UK Sites: Time in Each Level of Care (Level 0 and 1; Level 2; and/or Level 3) Through Discharge | Levels are defined according to National Framework Document: Level 0 - normal acute ward care (patients whose needs can be met through normal ward care in an acute hospital), Level 1 - acute ward care, with additional advice and support from the critical care team (Patients at risk of their condition deteriorating, or those recently relocated from higher levels of care, whose needs can be met on an acute ward with additional advice from a critical care team), Level 2 - more detailed observation or intervention (requiring more detailed observation or intervention including support for a single failing organ system or post-operative care and those 'stepping down' from higher levels of care) and Level 3 - advanced respiratory support alone, or basic respiratory support together with support of at least two organ systems (includes all complex patients requiring support for multi-organ failure). Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Baseline up to Hospital Discharge |
| Healthcare Resource Utilization: Team Managing the Participant During Hospitalization - Number of Healthcare Professional (HCP) Specialties Involved. (UK Participants Only) | Number of Healthcare Professional (HCP) Specialists involved with care of participant during hospitalization of UK participants.Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Baseline up to Day 365 |
| Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12month Follow-up. (UK Participants Only) | Number of Healthcare Professional (HCP) Specialists involved with care of participant for Venous Thromboembolism (VTE) after hospitalization through 365 days for UK participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Day 30 up to Day 365 |
| Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12 Month Follow-up. (UK Participants Only) | Number of Healthcare Professional (HCP) Specialists involved with care of participant for Venous Thromboembolism (VTE) after hospitalization through 365 days for UK participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Day 30 up to Day 365 |
| Healthcare Resource Utilization: Number of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only) | Number of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Day 30 up to Day 365 |
| Healthcare Resource Utilization: Duration of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only) | Duration of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | From Day 30 through Day 365 |
| Tallahassee |
| Florida |
| 32308 |
| United States |
| Florida Hospital Tampa | Tampa | Florida | 33613 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| University Hospital | Augusta | Georgia | 30901 | United States |
| St. Vincent Medical Group | Indianapolis | Indiana | 46260 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| East Jefferson General Hospital | Metairie | Louisiana | 70006 | United States |
| Detroit Medical Center | Detroit | Michigan | 48201 | United States |
| Mount Carmel Health System | Columbus | Ohio | 43213 | United States |
| UPMC Hamot | Erie | Pennsylvania | 16507 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Houston Methodist Sugarland Hospital | Richmond | Texas | 77469 | United States |
| Inova Alexandria Hospital | Alexandria | Virginia | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| Royal Devon & Exeter Hospital | Exeter | England | EX2 5DW | United Kingdom |
| Medway Maritime Hospital | Gillingham | England | ME7 5NY | United Kingdom |
| Royal Free Hospital | London | England | NW3 2QG | United Kingdom |
| St. Thomas Hospital | London | England | SE1 7EH | United Kingdom |
| Ninewells Hospital | Dundee | Scotland | DD1 9SY | United Kingdom |
| Tapson VF, Sterling K, Jones N, Elder M, Tripathy U, Brower J, Maholic RL, Ross CB, Natarajan K, Fong P, Greenspon L, Tamaddon H, Piracha AR, Engelhardt T, Katopodis J, Marques V, Sharp ASP, Piazza G, Goldhaber SZ. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: The OPTALYSE PE Trial. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1401-1410. doi: 10.1016/j.jcin.2018.04.008. |
| FG001 | APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| FG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| FG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| COMPLETED |
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| NOT COMPLETED |
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|
Overall number of participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | APT/2 Hours-r-tPA/2 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| BG001 | APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| BG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| BG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio to 48 ± 6 Hours After the Start of the APT Procedure | Change from baseline in RV/LV will be determined by computed tomographic angiography (CTA). | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | ratio | Change from Baseline to 48 hrs ± 6 hours |
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| Primary | Number of Participants With Major Bleeding Within 72 Hours After Initiating the APT Procedure | Criteria for major bleeding events, as defined by the International Society on Thrombosis and Haemostasis (ISTH): 1. Fatal bleeding and/or; 2. Symptomatic bleeding in a critical area or organ (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome) and/or; 3. Bleeding causing a fall in hemoglobin level of 20 grams/liter (g/L) or more, or leading to transfusion of two or more units of whole blood or red blood cells. | Safety population included all enrolled participants for whom the APT procedure was initiated. | Posted | Count of Participants | Participants | Day 3 (within 72 hours after initiating the APT procedure) |
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| Secondary | Percentage of Participants With Treatment Success of an APT Procedure | Treatment success of an APT procedure will be assessed by an Adjudication Committee that is blinded to the participant's treatment. The criteria for treatment success are defined as follows: A decrease in RV/LV from baseline to 48 hours after the start of the procedure of at least 0.2; and no life-threatening adverse events related to PE or its treatment through 30 days after the start of the APT procedure. | ITT population included all randomized participants. Here, 'Overall number of participants analyzed' signifies evaluable participants per clinical judgement of Adjudication Committee. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Baseline up to Day 30 |
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| Secondary | Change From Baseline in RV/LV at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph. | An echocardiogram was obtained at specified timepoints to evaluate RV/LV. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days) |
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| Secondary | Change From Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph | The extent of displacement of the tricuspid valves, termed as TAPSE was measured at specified timepoints using echocardiogram. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | Millimeters | Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days) |
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| Secondary | Change From Baseline in Estimated Right Ventricular Systolic Pressure (RVSP) at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph | RVSP was measured at specified timepoints using echocardiogram. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | Millimeters | Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days) |
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| Secondary | Percentage of Participants With Collapse of the Inferior Vena Cava (IVC) With Respiration at Days 0, 2, 30, 90, and 365, as Assessed by Echocardiograph | The collapse of IVC was measured at specified timepoints using echocardiogram. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day -2 [within -48 hrs of APT start]), Day 0 (within 4 hours after APT end), Day 2 (48 [± 6] hrs of APT start), Day 30 (± 5 days), Day 90 (± 10 days) and Day 365 (± 14 days) |
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| Secondary | Change From Baseline in Thrombus Burden by Miller Score as Assessed by Pulmonary Arteriogram (PAgram) at Day 0 | Miller score is composed of a score for arterial obstruction (objective score) and a score for reduction of peripheral perfusion of lungs (subjective evaluation). Right pulmonary artery (PA) is assigned 9 segmental arteries (3 to the upper, 2 to the middle, and 4 to the lower lobe), and left PA is assigned only 7 segmental arteries (2 to the upper, 2 to the lingula, and 3 to the lower lobe). Presence of segmental emboli, regardless of the degree of obstruction, is scored 1 point. Proximal emboli to the segmental level are scored a value equal to the number of segmental arteries arising distally. Maximal score of obstruction=16. Reduction of peripheral perfusion is scored by dividing each lung into upper, middle, and lower zones and by using a 4-point scale: 0=normal perfusion; 1=moderately reduced perfusion; 2=severely reduced perfusion; 3=no perfusion. Maximal score of reduced perfusion=18. Thus, the maximal Miller score =34. Higher Miller score=more thrombus burden. | ITT population included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants with available pre and post PAgrams. 'Number analyzed' = participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Day 0 (within 4 hours after APT end) |
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| Secondary | Change From Baseline in Thrombus Burden by Modified Miller Score as Assessed by CTA Scan at 48 ± 6 Hours After the Start of the APT Procedure | Modified miller score quantifies thrombus burden on CTA scans. Each segmental pulmonary artery (9 on the right, 7 on the left) that is fully or partly occluded by thrombus is given a score of 1. Any further proximal involves vessels score the number of segmental branches distal to that vessel, thereby giving a modified miller score of 0 (no thrombus) to 16 (thrombus in all segmental arteries or saddle embolism). | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoint. | Posted | Mean | Standard Deviation | units on a scale | From Baseline to 48 hrs ± 6 hours |
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| Secondary | Change in 6 Minute Walk (6MW) Distance From Day 30 to Day 90 and 365 | The 6 minute Walk Test is a measure of functional exercise capacity. Participants will be asked to walk as far as possible within a 6-minute period, and the distance covered at the end will be noted and recorded. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants with evaluable data at specified timepoint. | Posted | Mean | Standard Deviation | meters | Days 30, 90, 365 |
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| Secondary | Change in Borg Scale Score Before and After 6MW Distance Test at Days 30, 90, and 365 | Borg is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) and fatigue experienced before and after the 6MW distance test. Scores ranges from 0 (for no shortness of breath, or no fatigue) to 10 (for the greatest shortness of breath ever experienced, or maximum amount of fatigue felt). Higher scores indicates worse outcome. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories | Posted | Median | Inter-Quartile Range | units on a scale | Days 30, 90, and 365 |
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| Secondary | Number of Participants Who Received Oxygen Therapy | Oxygen source is categorized as room air, nasal prongs, mask, and intubated. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure for specified categories. | Posted | Count of Participants | Participants | Days 30, 90, and 365 |
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| Secondary | Change in Participant Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) 6b Score From Day 30 to Day 365 | PROMIS-PF 6b questionnaire is developed by including 2-items from item-improved Health Assessment Questionnaire (HAQ) and 4-items from item-improved Physical Function-10 (PF-10) instruments. Both of these instruments assess participant's present abilities. Both "Item-Improved instruments" have 5-response options: HAQ - 1="without any difficulty," 2="with a little difficulty," 3="with some difficulty," 4="with much difficulty," 5="unable to do"; PF-10 - 1="not at all," 2="very little," 3="somewhat," 4="quite a lot," 5="cannot do." Total score is the average of all scores of component items, which ranges from 0 (no disability) to 100 (worst disability). | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | units on a scale | Day 30, Day 365 |
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| Secondary | Change in Pulmonary Embolism Quality of Life (PEmb-QOL) Score From Day 30 to Day 365 | The PEmb-QoL questionnaire contains 6 dimensions that has been created based on the contents of the items, frequency of complaints (Question [Q]1; score range: 1 [every day] to 5 [never]), activities of daily living (ADL) limitations (Q4; score range: 1 [limited a lot] to 3 [not at all]), work-related problems (Q5; response: yes/no), social limitations (Q6; score range: 1 [not at all] to 5 [extremely]), intensity of complaints (Q7 [pain in chest/shoulders]/8 [breathlessness]; score range: 1 [none] to 6 [very serious]) and emotional complaints (Q9; score range: 1 [at all times] to 6 [none of the times]). Total Score for all dimensions are calculated by the sum of the scores for each item of the dimension divided by the number of items. Total score ranges from 1 (better quality of life) to 100 (worst quality of life). Higher scores indicate poorer outcome (decreased quality of life). Questions 1, 4, 5, and 9 are reverse scored. Questions 2 and 3 provide descriptive information. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | units on a scale | Day 30, Day 365 |
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| Secondary | Number of Participants Who Encountered Technical Procedural Complications | Technical complications associated with the use of the EKOS device will be recorded during catheter placement in the pulmonary artery and during the infusion procedure. | Safety population included all enrolled participants for whom the APT procedure was initiated. | Posted | Count of Participants | Participants | From device placement through Day 2 |
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| Secondary | Number of Participants With Symptomatic Recurrent Pulmonary Embolism (Per Adjudication) | Number of participants with symptomatic recurrent pulmonary embolism up to 365 days following the APT procedure, were reported. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Safety population included all enrolled participants for whom the APT procedure was initiated. | Posted | Count of Participants | Participants | From Baseline up to Day 365 |
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| Secondary | Number of Participants Who Die Due to Any Cause | Number of participants who died due to any cause for up to 365 days following the APT procedure, were reported. | Safety population included all enrolled participants for whom the APT procedure was initiated. | Posted | Count of Participants | Participants | From Baseline up to Day 365 |
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| Secondary | For Participants of UK Sites: Freedom From Major Harm Occurring Between Enrolment and 30 Days | Number of UK participants with freedom from major harms assessed by Safety Monitor using the following criteria: 1) Mortality - all cause and PE related; 2) Cardiovascular (CV) collapse defined as one or more of the following: a) Greater than (>) 40 millimeters of mercury (mmHg) drop in systolic blood pressure (SBP) (for >15 minutes from documented blood pressure as an in-patient) despite intravenous (IV) fluid challenge and absence of new atrial arrhythmia; b) Requirement for emergency systemic thrombolysis; c) Requirement for emergency surgical embolectomy ; d) Requirement for vasopressors; e)and/or Intubation/Ventilation; 3) Major bleeding per ISTH; 4) Recurrent PE (confirmed by imaging); and/or 5) Surgical correction of device related complication. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants with evaluable data at specified timepoint. | Posted | Count of Participants | Participants | From Baseline up to Day 30 |
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| Secondary | For Participants of UK Sites:Change in EuroQual - 5 Dimensions - 5 Levels (EQ-5D-5L) Score From Day 30 to Day 365 | The EQ-5D-5L consists of 2 parts - the descriptive system (Index Score) and the EQ Visual Analogue scale (VAS Score). The EQ-5D-5L descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Each one digit number expressing the level selected for each dimension is combined into a 5-digit number describing the respondent's heath state. These 5-digit numbers are converted into an index value, where 1 represents full health and 0 is equivalent to death. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale with 100 being the best health imaginable and 0 being the worst health imaginable. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | units on a scale | Day 30, Day 365 |
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| Secondary | For Participants of UK Sites: Time From Hospital Admission to Diagnosis of PE | Duration of time between hospital admission and the diagnosis of pulmonary embolism (PE) measured in hours for UK participants.Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints | Posted | Mean | Standard Deviation | hour | From Baseline through Day 3 |
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| Secondary | For Participants of UK Sites: Time From Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for PE | Duration of time between Diagnostic Computed Tomography (CT) Scan to Initiation of Treatment for pulmonary embolism (PE) measured in hours for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | hour | From Baseline through Day 3 |
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| Secondary | For Participants of UK Sites: Time in Each Level of Care (Level 0 and 1; Level 2; and/or Level 3) Through Discharge | Levels are defined according to National Framework Document: Level 0 - normal acute ward care (patients whose needs can be met through normal ward care in an acute hospital), Level 1 - acute ward care, with additional advice and support from the critical care team (Patients at risk of their condition deteriorating, or those recently relocated from higher levels of care, whose needs can be met on an acute ward with additional advice from a critical care team), Level 2 - more detailed observation or intervention (requiring more detailed observation or intervention including support for a single failing organ system or post-operative care and those 'stepping down' from higher levels of care) and Level 3 - advanced respiratory support alone, or basic respiratory support together with support of at least two organ systems (includes all complex patients requiring support for multi-organ failure). Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | hour | From Baseline up to Hospital Discharge |
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| Secondary | Healthcare Resource Utilization: Team Managing the Participant During Hospitalization - Number of Healthcare Professional (HCP) Specialties Involved. (UK Participants Only) | Number of Healthcare Professional (HCP) Specialists involved with care of participant during hospitalization of UK participants.Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | HCP per participant | From Baseline up to Day 365 |
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| Secondary | Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12month Follow-up. (UK Participants Only) | Number of Healthcare Professional (HCP) Specialists involved with care of participant for Venous Thromboembolism (VTE) after hospitalization through 365 days for UK participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | HCP visits per participant | From Day 30 up to Day 365 |
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| Secondary | Healthcare Resource Utilization: Number of Healthcare Professionals (HCP) Visits for Venous Thromboembolism (VTE) After Hospitalization and During 12 Month Follow-up. (UK Participants Only) | Number of Healthcare Professional (HCP) Specialists involved with care of participant for Venous Thromboembolism (VTE) after hospitalization through 365 days for UK participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | HCP visits per participant | From Day 30 up to Day 365 |
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| Secondary | Healthcare Resource Utilization: Number of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only) | Number of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Count of Participants | Participants | From Day 30 up to Day 365 |
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| Secondary | Healthcare Resource Utilization: Duration of Hospital Re-Admissions After Hospitalization and During 12 Month Follow-up. (UK Participants Only) | Duration of Hospital Re-Admissions after hospitalization and during 12 month follow-up for UK Participants. Due to changes in the protocol, there were no subjects enrolled in the UK in Treatment Arm 4. | ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for this outcome measure at specified timepoints. | Posted | Mean | Standard Deviation | Days per subject | From Day 30 through Day 365 |
|
From Baseline up to Day 365
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | APT/2 Hours-r-tPA/2 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 2 mg/hour [hr]/catheter) will be delivered through Ekosonic® Endovascular Device (EKOS) ultrasonic infusion catheter for 2 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. | 1 | 37 | 11 | 37 | 9 | 37 |
| EG001 | APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. | 1 | 37 | 15 | 37 | 22 | 37 |
| EG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. | 0 | 37 | 12 | 37 | 10 | 37 |
| EG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. | 1 | 18 | 4 | 18 | 6 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aneamia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia postoperative | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
| ||
| Intra-abdominal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Multi-organ failure | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Herpes zoster disseminated | Infections and infestations | Systematic Assessment |
| ||
| Orchitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Anticoagulation drug level below therapeutic | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myeloproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Haemorrhage intracranial | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin necrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Haemorrhage | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Peripheral arterial occlusive disease | Vascular disorders | Systematic Assessment |
| ||
| Post thrombotic syndrome | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia postoperative | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac flutter | Cardiac disorders | Systematic Assessment |
| ||
| Antithrombin III deficiency | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Gravitational oedema | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Peripheral swelling | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Vessel puncture site haemorrhage | General disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Device related infection | Infections and infestations | Systematic Assessment |
| ||
| Herpes zoster | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Viral infection | Infections and infestations | Systematic Assessment |
| ||
| Laceration | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Coagulation factor VIII level increased | Investigations | Systematic Assessment |
| ||
| Heart rate decreased | Investigations | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Seizure | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Mental Status Changes | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Postoperative renal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Withdrawl bleed | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleurisy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary alveolar haemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy O'Connell | Boston Scientific | 763-494-2706 | nancy.oconnell@bsci.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2019 | Jan 7, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| African American, not of Hispanic origin |
|
| Hispanic or Latino |
|
| Asian or Pacific Islander |
|
| Other |
|
| United Kingdom |
|
|
| Change at 48 ± 6 hours |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
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| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
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|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
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|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
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|
| OG001 | APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 |
| APT/6 Hours-r-tPA/1 mg/hr/Catheter |
A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG001 | APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| APT/6 Hours-r-tPA/1 mg/hr/Catheter |
A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG001 | APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG001 | APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG001 | APT/4 Hours-r-tPA/1 mg/hr/Catheter | A total of 4 or 8 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 4 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
|
|
| OG002 | APT/6 Hours-r-tPA/1 mg/hr/Catheter | A total of 6 or 12 mg r-tPA (as 1 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
| OG003 | APT/6 Hours-r-tPA/2 mg/hr/Catheter | A total of 12 or 24 mg r-tPA (as 2 mg/hr/catheter) will be delivered through EKOS ultrasonic infusion catheter for 6 hrs. Ekosonic® Endovascular Device ultrasonic infusion catheter: r-tPA will be administered via EKOS. Recombinant tissue plasminogen activator: Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm. |
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