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This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.
The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure.
The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-Seal System | Experimental | The Cross-Seal System will be used in all subjects enrolled in the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cross-Seal System | Device | Use of the Cross-Seal system to close the femoral arteriotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Major Complications | Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection | 30 days post procedure |
| Mean Time To Hemostasis (TTH) | The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device. | Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Minor Complications | The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence | 30 days post procedure |
| Number of Participants With Device Related Complications Within 30 Days Post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria
Prior intra-aortic balloon pump at access site
Subjects with severe inflow disease (iliac artery diameter stenosis > 50%) and/or severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography Imaging, duplex ultrasound, and/or intra-procedural fluoroscopy
Common femoral artery lumen diameter is < 5 mm
In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
Prior target artery closure with any closure device < 90 days, or closure with manual compression ≤ 30 days prior to index procedure
Prior vascular surgery, vascular graft, or stent in region of access site
Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
Subjects with significant anemia
Subject with known bleeding disorder including thrombocytopenia (platelet count < 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
Subject with renal insufficiency, on dialysis therapy, or with renal transplant
Known severe allergy to contrast reagent that cannot be managed with premedication
Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment
Planned anticoagulation therapy post-procedure such that the Activated Clotting Time (ACT) is expected to be elevated above 350 seconds for more than 24 hours after the procedure
Connective tissue disease (e.g., Marfan's Syndrome)
Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
Subjects who are morbidly obese
Planned major intervention or surgery, including planned endovascular procedure in the target leg, within 30 days following the interventional procedure
Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed)
Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
Known allergy to any device component
Subject is known or suspected to be pregnant or lactating
Evidence of active systemic or local groin infection
Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating
Subject is mentally incompetent or a prisoner
New York Heart Association (NYHA) Class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit within 24 hours prior to the index procedure
Left Ventricular Ejection Fraction (LVEF) < 20%
Unilateral or bilateral lower extremity amputation
Known existing nerve damage in the target leg
Subjects who have already participated in this study
Intra-Procedure Exclusion Criteria
Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
Ipsilateral femoral venous sheath during the catheterization procedure
Common femoral artery calcium, which is visible with prior Computed Tomography Imaging and/or duplex ultrasound
Subject in which there is difficulty inserting the introducer sheath or need for greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
Evidence of a pre-existing hematoma (> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior Computed Tomography imaging, fluoroscopy, and/or duplex ultrasound
Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
Target arteriotomy >18 French sheath
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| Name | Affiliation | Role |
|---|---|---|
| Mazin Foteh, MD | Cardiothoracic and Vascular Surgeons - Austin | Principal Investigator |
| Prakash Krishnan | Icahan School of Medicine at Mt Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Institute of the Rockies | Denver | Colorado | 80218 | United States | ||
| River City Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38708595 | Derived | Krishnan P, Farhan S, Zidar F, Krajcer Z, Metzger C, Kapadia S, Moore E, Nazif T, Garland T, Zhang M, Khera S, Sharafuddin M, Patel VI, Bacharach JM, Coady P, Schermerhorn ML, Shames ML, Rahimi S, Panneton JM, Elkins C, Foteh M. Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System. Circ Cardiovasc Interv. 2024 Jun;17(6):e013842. doi: 10.1161/CIRCINTERVENTIONS.123.013842. Epub 2024 May 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transfemoral Approach | Closure of Common Femoral Artery site of subjects who have undergone interventional catheterization procedure using 8-18FR ID sheaths. |
| 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 | Jul 29, 2020 | Apr 30, 2024 |
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Performance goal
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Number of subjects with devices related complications as adjudicated by the Clinical Events Committee. |
| 30 days post procedure |
| Incidence of Adverse Events | Incidence of major and minor Adverse Events (AEs) | 60 days post procedure |
| Incidence of Technical Success | Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only). | Immediately Post-procedure (procedure approximately 8 hours) |
| Incidence of Closure Success | Incidence of access site closure success: defined as technical success and freedom from major complications | Within 48 hours of the index procedure or hospital discharge, whichever occurs first |
| Incidence of Treatment Success | Incidence of Treatment Success: defined as technical success and freedom from major complications | 30 days post procedure |
| Incidence of Surgical or Endovascular Intervention Post Closure | Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention. | 30 days post procedure |
| Incidence of Manual Compression | Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only). | Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours |
| Time-to-Ambulation: | Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding. | From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours |
| Incidence of Device Failure | Incidence of subjects experiencing Device Failure. | 30 days post procedure |
| Incidence of Procedure Related Complications | Number of subjects with procedure related complications as adjudicated by the CEC. | 30 days post procedure |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| University of South Florida | Tampa | Florida | 33620 | United States |
| University of Iowa Hospital | Iowa City | Iowa | 52242 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Rutgers, The State University of New Jersey | Piscataway | New Jersey | 08854 | United States |
| Mt Sinai Medical Center | New York | New York | 10029 | United States |
| The Trustees of Columbia University in the City of New York | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Good Samaritan Hospital | Cincinnati | Ohio | 45220 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| INTEGRIS Cardiovascular Physicians | Oklahoma City | Oklahoma | 73112 | United States |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | 19096 | United States |
| North Central Heart | Sioux Falls | South Dakota | 57108 | United States |
| Holston Valley Medical Center | Kingsport | Tennessee | 37660 | United States |
| Cardiothoracic and Vascular Surgeons | Austin | Texas | 78756 | United States |
| St. David's Heart and Vascular dba Austin heart | Austin | Texas | 78756 | United States |
| Texas Heart Institute and Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Sentara Medical Group | Norfolk | Virginia | 23502 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Transfemoral Approach | Closure of Common Femoral Artery site of subjects who have undergone interventional catheterization procedure using 8-18FR ID sheaths. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Freedom From Major Complications | Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection | Pivotal safety cohort included 96 subjects from the full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects. | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
| ||||||||||||||||||||||||||
| Primary | Mean Time To Hemostasis (TTH) | The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device. | Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Number of participants analyzed is 101 as 9 subjects who had an adjunctive intervention and 4 subjects who did not receive the investigational device. | Posted | Mean | Standard Deviation | Minutes | Index Procedure |
|
| ||||||||||||||||||||||||||
| Secondary | Freedom From Minor Complications | The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence | Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects. | Posted | Count of Participants | Participants | 30 days post procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Device Related Complications Within 30 Days Post-procedure | Number of subjects with devices related complications as adjudicated by the Clinical Events Committee. | Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects. | Posted | Count of Participants | Participants | 30 days post procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events | Incidence of major and minor Adverse Events (AEs) | Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. | Posted | Count of Participants | Participants | 60 days post procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Technical Success | Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only). | Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 4 subjects, the analysis was conducted on 110 subjects. | Posted | Count of Participants | Participants | Immediately Post-procedure (procedure approximately 8 hours) |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Closure Success | Incidence of access site closure success: defined as technical success and freedom from major complications | Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 2 subjects, the analysis was conducted on 112 subjects. | Posted | Count of Participants | Participants | Within 48 hours of the index procedure or hospital discharge, whichever occurs first |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Treatment Success | Incidence of Treatment Success: defined as technical success and freedom from major complications | Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 3 subjects, the analysis was conducted on 111 subjects. | Posted | Count of Participants | Participants | 30 days post procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Surgical or Endovascular Intervention Post Closure | Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention. | Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 4 subjects, the analysis was conducted on 110 subjects. | Posted | Count of Participants | Participants | 30 days post procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Manual Compression | Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only). | Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 3 subjects, the analysis was conducted on 111 subjects. | Posted | Count of Participants | Participants | Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours |
|
| |||||||||||||||||||||||||||
| Secondary | Time-to-Ambulation: | Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding. | Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 6 subjects, the analysis was conducted on 108 subjects. | Posted | Mean | Standard Deviation | Hours | From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours |
|
| ||||||||||||||||||||||||||
| Secondary | Incidence of Device Failure | Incidence of subjects experiencing Device Failure. | Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). | Posted | Count of Participants | Participants | 30 days post procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Procedure Related Complications | Number of subjects with procedure related complications as adjudicated by the CEC. | Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects. | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
From time of enrollment through study completion (up to 60 days).
Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
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 | Cross-Seal System | The Cross-Seal System will be used in all subjects enrolled in the study Cross-Seal System: Use of the Cross-Seal system to close the femoral arteriotomy | 1 | 147 | 42 | 147 | 63 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Acute respiratory failure | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arterial perforation | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Atrioventricular block | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 21.0 | Systematic Assessment | Thoracic graft migration |
|
| Electrocardiogram PR prolongation | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Femoral artery dissection | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Peripheral artery occlusion | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Peripheral artery stenosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Respiratory failure | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
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| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Stent-graft endoleak | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Syncope | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Vascular access site haematoma | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vascular access site haemorrhage | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia postoperative | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atheroembolism | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Balance disorder | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Bundle Branch Block Left | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Burning sensation | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Carotid bruit | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Chest discomfort | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Chest pain | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Deafness unilateral | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Dizziness | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Ecchymosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Ecchymosis | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Electrocardiogram QRS complex prolonged | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Gastroenteritis viral | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Nodule | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema peripheral | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Petechiae | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Procedural pain | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Rectal tenesmus | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Shock | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Stenosis | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Syncope | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
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| Vascular access site bruising | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vascular access site haematoma | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Vascular access site haematoma | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
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| Vascular access site haemorrhage | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Vascular access site pseudoaneurysm | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Vascular access site thrombosis | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Terumo Medical Corporation | 9085146154 | charis.sugden@terumomedical.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2020 | Apr 30, 2024 | SAP_001.pdf |
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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