Angio-Seal Interventional Radiology (IR) Registry
- Conditions
- Diagnostic and/or Interventional Radiology Procedures
- Registration Number
- NCT01222104
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient populations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 634
- Patient is undergoing a diagnostic and/or interventional radiology procedure via femoral arterial access and the investigator performing the procedure would use Angio-Seal for closure as part of his/her routine care of the patient. Angio-Seal deployment will follow the standard of care for vascular closure device use and the Instructions for Use (IFU) for the device.
- Sheath angiography prior to Angio-Seal deployment reveals appropriate anatomy and puncture location for vascular closure device deployment.
- Patients who are unable to provide written informed consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Major Vascular Complications 30 days Collect data on patients who have undergone a diagnostic and/or interventional radiology procedure in which the St. Jude Medical (SJM) Angio-Seal Evolution or V-Twist Integrated Platform (VIP) Device was deployed, to evaluate the rate of major vascular complications out to 30 days post-procedure.
The following are defined as a major vascular complication:
1. Vascular injury requiring repair via surgery, angioplasty, ultrasound guided compression, thrombin injection, or other means;
2. Permanent (unresolved at 30-day post-procedure evaluation) access site-related nerve injury or access site-related nerve injury requiring intervention;
3. Access site related bleeding requiring transfusion;
4. New ipsilateral lower extremity ischemia requiring surgical intervention;
5. Retroperitoneal bleeding;
6. Generalized infection requiring prolonged hospitalization and/or treatment with IV antibiotics;
7. Access related complication that results in extended hospital stay;
8. Death
- Secondary Outcome Measures
Name Time Method Time to Hemostasis Procedure Time-to-hemostasis stratified into 3 categories: hemostasis in less than 1 minute alone or in combination with manual compression (standard of care), 1-5 minutes alone or in combination with manual compression (standard of care), and/or hemostasis achieved \>5 minutes and/or with additional hemostasis methods required.
Rate of Minor Vascular Complications 30 days The following are defined as a minor vascular complication:
1. Unanticipated access site bleeding requiring ≥ 30 minutes of manual compression to re-achieve hemostasis;
2. Ipsilateral hematoma \>10 cm;
3. Ipsilateral pseudoaneurysm without intervention;
4. Ipsilateral arteriovenous fistula;
5. Ipsilateral deep vein thrombosis;
6. Local access site infection without prolonged hospitalizationImpact of Guided Access on Use of Closure Device. 30 days The influence of fluoroscopy and/or ultrasound guided access on the decision to use a closure device.
Impact of Guided Access on Achieving Target Puncture Location. 30 days The influence of fluoroscopy and/or ultrasound guided access on puncture location.
Rate of Major Vascular Complications (MVCs) by Guided Access Mode. 30 days The influence of fluoroscopy and/or ultrasound guided access on Major Vascular Complications (MVCs).
Rate of Minor Vascular Complications by Guided Access Mode. 30 days The influence of fluoroscopy and/or ultrasound guided access on minor vascular complications.
Impact of Peripheral Vascular Disease (PVD) on Use of Closure Device 30 days Presence of peripheral vascular disease (PVD) and its effect on the decision to use a closure device
Impact of Peripheral Vascular Disease (PVD) on Achieving Hemostasis by Device 30 days Presence of peripheral vascular disease (PVD) and its effect on hemostasis. Initial hemostasis by device achieved.
Rate of Major Vascular Complications (MVC) by Presence of Peripheral Vascular Disease (PVD) 30 days Presence of peripheral vascular disease (PVD) and its effect on Major Vascular Complications (MVC).
Rate of Minor Vascular Complications by Presence of Peripheral Vascular Disease (PVD) 30 days Presence of peripheral vascular disease (PVD) and its effect on minor vascular complications.
Trial Locations
- Locations (10)
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Baptist Cardiac and Vascular Institute
🇺🇸Miami, Florida, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Thomas Jefferson Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Mayfield Clinic, Inc.; The University Hospital
🇺🇸Cincinnati, Ohio, United States
Kaleida Health
🇺🇸Buffalo, New York, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States