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| Name | Class |
|---|---|
| BTG International Inc. | OTHER |
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This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.
For the prospective arm of the registry, a physician will have selected the APT procedure for the treatment of pulmonary embolism. The APT treatment and follow-up assessments are per clinical judgement and institutional standard of care which may vary at each clinical site.
For the retrospective arm of the registry, the investigators will gather data from consecutive cases of individuals who received the APT treatment for pulmonary embolism. Specific baseline, treatment, and long-term health information is collected and de-identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective | Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation. |
| |
| Prospective | Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EkoSonic Endovascular System with thrombolytic | Device | The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | Difference (percent change) in the measurement of the right ventricular to left ventricular diameters (RV/LV) ratio as measured on baseline echocardiogram to post-procedure echocardiogram (24-48 hours post initiation of therapy). | Baseline to post-procedure (end of procedure through hospital discharge up to 14 days) |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days. | Post-procedure hospitalization through hospital discharge up to 14 days |
| Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response. | From date of enrollment up to or until the placement of the Ekos device, on average 48 hours. |
| Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | Number of subjects experiencing a SAE related to EKOS device and/or procedure from time of procedure through the first 12 months post-APT procedure, measured by frequency and severity of events. | From time of APT procedure through 12 months post-procedure. |
| All-cause Mortality During First 12 Months Post-procedure. | Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure. | Start of procedure through 12 months post-procedure. |
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Retrospective Inclusion Criteria:
Retrospective Exclusion Criteria:
Prospective Inclusion Criteria:
Prospective Exclusion Criteria:
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Individuals with intermediate-high and high risk pulmonary embolism who are selected to receive treatment using the EKOS device and thrombolytic.
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| Name | Affiliation | Role |
|---|---|---|
| Keith Sterling, MD | Inova Alexandria Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthfinity, PLLC Advanced Cardiac & Vascular Clinic | Glendale | Arizona | 85308 | United States | ||
| Cedars - Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38264938 | Derived | Sterling KM, Goldhaber SZ, Sharp ASP, Kucher N, Jones N, Maholic R, Meneveau N, Zlotnick D, Sayfo S, Konstantinides SV, Piazza G. Prospective Multicenter International Registry of Ultrasound-Facilitated Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism (KNOCOUT PE). Circ Cardiovasc Interv. 2024 Mar;17(3):e013448. doi: 10.1161/CIRCINTERVENTIONS.123.013448. Epub 2024 Jan 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Retrospective | Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation. EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. |
| 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 19, 2018 | Sep 29, 2021 |
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|
| Healthcare Utilization | Summary of healthcare utilization from date of enrollment through discharge. | Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure). |
| Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits | Reported as percent change in the PEmb-QOL questionnaire score from baseline timepoint to 3 months and 12 months. The PEmb-QOL measures patient's quality of life following pulmonary embolism on a scale of 1 through 5, with lower scores indicating a better outcome. | Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up. |
| Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Reported as change in the VAS, Utility and Misery questionnaire scores from baseline timepoint and/or study visit to 3 months and 12 months. The VAS (Visual Analogue Scale) is a one question, unidimensional measure of pain intensity where a subject is asked to rate his pain on a scale of 100 through 1, with 100 indicating the best health imaginable through 1 indicating the worst health imaginable. Higher scores indicate a better outcome. The EQ-5D is a series of questions that measures Quality of Life on a scale of 0 through 5. 0 indicates no problems in daily activities and 5 indicates inability to perform daily activities. The total score is added up and compared to the total scale from 0 to 25, with 0 indicating no problems in daily activities and 25 indicating inability to perform daily activities. A lower score indicates a better outcome. | Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients. |
| Number of Patients Needing an IVC Filter Placement | Measured by number patients with an occurrence of needing an IVC filter placement. | From date of procedure through 12 months |
| Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Measured by number of patients experiencing adverse events related to major bleeding events from time of procedure through the first 12 months post-procedure by frequency and severity (mild, moderate, severe). | From post-procedure through 12-months post-procedure |
| Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity. | From post-procedure through 12-months post-procedure |
| Diagnosis of Pulmonary Hypertension Diagnosis | New onset pulmonary hypertension defined as mean pulmonary artery pressure greater than 25 mm Hg by echocardiogram that persists at least 3 months after PE. | Analyzed 12 months post-procedure |
| Los Angeles |
| California |
| 90048 |
| United States |
| Radiology Imaging Associates | Englewood | Colorado | 80112 | United States |
| Bradenton Cardiology Center | Bradenton | Florida | 34205 | United States |
| Delray Medical Center | Delray Beach | Florida | 33484 | United States |
| St. Vincent's Healthcare | Jacksonville | Florida | 32204 | United States |
| University of Florida | Jacksonville | Florida | 32209 | United States |
| Memorial Hospital | Jacksonville | Florida | 32216 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Orlando Health, Inc. | Orlando | Florida | 32806 | United States |
| Tallahassee Research Institute, Inc | Tallahassee | Florida | 32308 | United States |
| AdventHealth Tampa Pepin Heart Institute | Tampa | Florida | 33613 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| WellStar Medical Group | Marietta | Georgia | 30060 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| St. Mary Medical Center | Hobart | Indiana | 46342 | United States |
| St. Vincent Hospital | Indianapolis | Indiana | 46260 | United States |
| St. Elizabeth Healthcare | Crestview Hills | Kentucky | 41017 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Jewish Hospital | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| St. Vincent Hospital/Reliant Medical Group | Worcester | Massachusetts | 01608 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Ascension St. John Hospital | Detroit | Michigan | 88236 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Metro Health - University of Michigan Health | Wyoming | Michigan | 49519 | United States |
| Cardiology Associates of Northern Mississippi | Oxford | Mississippi | 38655 | United States |
| Saint Louis University Hospital | St Louis | Missouri | 63110 | United States |
| Dartmouth - Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cooper University Healthcare | Camden | New Jersey | 08103 | United States |
| University of Buffalo | Buffalo | New York | 14203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Summa Health | Akron | Ohio | 44304 | United States |
| Mercy Health Cincinnati | Cincinnati | Ohio | 45211 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| TriHealth Good Samaritan Bethesda North | Cincinnati | Ohio | 45220 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Mount Caramel East Hospital | Columbus | Ohio | 43213 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| Genesis Healthcare System | Zanesville | Ohio | 43701 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| St. Vincent Hospital, Allegheny Health Network | Erie | Pennsylvania | 16502 | United States |
| Temple University Hospital, Department of Thoracic Medicine & Surgery | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UPMC Hamot | Pittsburgh | Pennsylvania | 15219 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| Lexington Cardiology | West Columbia | South Carolina | 29169 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Hendrick Medical Center | Abilene | Texas | 79601 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Houston Methodist Sugarland | Sugar Land | Texas | 77479 | United States |
| Inova Alexandria Hospital | Alexandria | Virginia | 22304 | United States |
| Sentara Vascular Specialists | Norfolk | Virginia | 23507 | United States |
| Providence Regional Medical Center | Everett | Washington | 98201 | United States |
| Inland Imaging | Spokane | Washington | 99204 | United States |
| CAMC | Charleston | West Virginia | 25304 | United States |
| West Virginia University Heart & Vascular Institute | Morgantown | West Virginia | 26505 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53205 | United States |
| Medical University of Vienna | Vienna | Austria |
| CHRU jean Minjoz, Pôle cœur-Poumons | Besançon | France |
| Hôpital Nord, APHM | Marseille | 13015 | France |
| Johannes Gutenberg Univeristy Mainz | Mainz | 55099 | Germany |
| Technical University Munchen | München | 80333 | Germany |
| University Medical Center Uterecht | Utrecht | Netherlands |
| Swiss Cardiovascular Center | Bern | Switzerland |
| University Hospital Zurich | Zurich | Switzerland |
| Acibadem University School of Medicine | Istanbul | 34662 | Turkey (Türkiye) |
| Royal Devon and Exeter Hospital | Exeter | United Kingdom |
| Medway NHS Foundation Trust | Gillingham | United Kingdom |
| Oxford University Hospitals | Headington | OX3 0BL | United Kingdom |
| Royal Free | London | NW3 2QG | United Kingdom |
| Guy's & St Thomas' NHS Foundation Trust | London | SE1 7EH | United Kingdom |
| St. Mary's Hospital | London | United Kingdom |
| FG001 | Prospective | Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion. EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Retrospective | Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation. EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. |
| BG001 | Prospective | Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion. EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Baseline Medical History | Count of Participants | Participants |
|
| 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 in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | Difference (percent change) in the measurement of the right ventricular to left ventricular diameters (RV/LV) ratio as measured on baseline echocardiogram to post-procedure echocardiogram (24-48 hours post initiation of therapy). | Subjects with matched pairs (pre-procedure echocardiogram and post-procedure echocardiogram through discharge from index hospitalization) have been reported. | Posted | Mean | Standard Deviation | Percent change | Baseline to post-procedure (end of procedure through hospital discharge up to 14 days) |
|
|
| ||||||||||||||||||||||||||||
| Primary | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days. | Posted | Count of Participants | Participants | Post-procedure hospitalization through hospital discharge up to 14 days |
| ||||||||||||||||||||||||||||||||
| Primary | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response. | Posted | Count of Participants | Participants | From date of enrollment up to or until the placement of the Ekos device, on average 48 hours. |
| ||||||||||||||||||||||||||||||||
| Primary | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | Number of subjects experiencing a SAE related to EKOS device and/or procedure from time of procedure through the first 12 months post-APT procedure, measured by frequency and severity of events. | Posted | Count of Participants | Participants | From time of APT procedure through 12 months post-procedure. |
| ||||||||||||||||||||||||||||||||
| Primary | All-cause Mortality During First 12 Months Post-procedure. | Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure. | Retrospective data to be updated. | Posted | Count of Participants | Participants | Start of procedure through 12 months post-procedure. |
|
| ||||||||||||||||||||||||||||||
| Primary | Healthcare Utilization | Summary of healthcare utilization from date of enrollment through discharge. | Posted | Median | Inter-Quartile Range | Hours | Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure). |
|
| ||||||||||||||||||||||||||||||
| Primary | Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits | Reported as percent change in the PEmb-QOL questionnaire score from baseline timepoint to 3 months and 12 months. The PEmb-QOL measures patient's quality of life following pulmonary embolism on a scale of 1 through 5, with lower scores indicating a better outcome. | QOL date were not collected in the retrospective cohort. These questionnaires were only collected prospectively. | Posted | Mean | Standard Deviation | percentage change | Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up. |
| ||||||||||||||||||||||||||||||
| Primary | Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Reported as change in the VAS, Utility and Misery questionnaire scores from baseline timepoint and/or study visit to 3 months and 12 months. The VAS (Visual Analogue Scale) is a one question, unidimensional measure of pain intensity where a subject is asked to rate his pain on a scale of 100 through 1, with 100 indicating the best health imaginable through 1 indicating the worst health imaginable. Higher scores indicate a better outcome. The EQ-5D is a series of questions that measures Quality of Life on a scale of 0 through 5. 0 indicates no problems in daily activities and 5 indicates inability to perform daily activities. The total score is added up and compared to the total scale from 0 to 25, with 0 indicating no problems in daily activities and 25 indicating inability to perform daily activities. A lower score indicates a better outcome. | Data for the retrospective cohort were not captured as Quality of Life questionnaires were not Standard of Care at most institutions. | Posted | Mean | Standard Deviation | units on a scale | Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients. |
| ||||||||||||||||||||||||||||||
| Primary | Number of Patients Needing an IVC Filter Placement | Measured by number patients with an occurrence of needing an IVC filter placement. | Posted | Count of Participants | Participants | From date of procedure through 12 months |
|
| |||||||||||||||||||||||||||||||
| Primary | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Measured by number of patients experiencing adverse events related to major bleeding events from time of procedure through the first 12 months post-procedure by frequency and severity (mild, moderate, severe). | Posted | Count of Participants | Participants | From post-procedure through 12-months post-procedure |
| ||||||||||||||||||||||||||||||||
| Primary | Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity. | Posted | Count of Participants | Participants | From post-procedure through 12-months post-procedure |
| ||||||||||||||||||||||||||||||||
| Primary | Diagnosis of Pulmonary Hypertension Diagnosis | New onset pulmonary hypertension defined as mean pulmonary artery pressure greater than 25 mm Hg by echocardiogram that persists at least 3 months after PE. | Posted | Count of Participants | Participants | Analyzed 12 months post-procedure |
|
|
Adverse Events were collected on or after the date of the procedure through 12 months. Data presented are for prospective and retrospective patients through the 12 month follow up visit.
Only TEAEs (Treatment Emergent Adverse Event), defined as AEs starting on or after the date of intervention are included in this table. Patients are counted at most once for each preferred MedDRA term. Some patients were not followed for the full 12 months due to retrospective data collection and prospective data collection ending prior to the last patient reaching 12 months.
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 | Retrospective | Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation. EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. | 50 | 991 | 100 | 991 | 63 | 991 |
| EG001 | Prospective | Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion. EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. | 15 | 489 | 39 | 489 | 40 | 489 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Atroventricular block, complete | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Dyspnoea | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Endocarditis, bacterial | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Reperfusion arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Colon cancer, metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Lung cancer, metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Neoplasm, malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Neuroendocrine tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| |
| Subdural haematoma | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chronic pulmonary obstructive disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal wall haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cardiogenic shock | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebellar haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebral infarction | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Compartment syndrome | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Embolism, venous | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haematochezia | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haematuria | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haemoptysis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haemorrhage, intracranial | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Internal haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lacunar infarction | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Post procedural haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary embolism | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Retroperitoneal haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Retroperitoneal haemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Shock, hemorrhagic | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Subdural haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vaginal hemorrhage | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vascular access site haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Vein Thrombosis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Cass | Boston Scientific | 206-641-4529 | Leslie.Cass@bsci.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2019 | Sep 29, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D013927 | Thrombosis |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013923 | Thromboembolism |
Not provided
Not provided
| Female |
|
| No Answer |
|
| African American |
|
| Other |
|
| Unknown or Missing |
|
| BMI ≥30.0 kg/m² |
|
| Family History of Venous Thromboembolism |
|
| History of Cancer in Remission |
|
| Congestive Heart Failure |
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| OG001 | Prospective | Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion. EkoSonic Endovascular System with thrombolytic: The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots. |
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