RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System
- Conditions
- Peripheral Vascular DiseaseCardiovascular Disease
- Interventions
- Device: Vessel Closure (StarClose™)
- Registration Number
- NCT00736086
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.
- Detailed Description
To evaluate the StarClose™ VCS in the femoral artery in subjects who are ambulated early post-percutaneous cardiac or peripheral vascular, diagnostic catheterization procedure. The clinical use of vascular closure devices for rapid hemostasis after femoral access was first reported in 1991. 18 participants may be ambulated almost immediately after diagnostic coronary angiography and discharged many hours earlier than currently practiced in most centers utilizing a supine restriction period of 6 hours after diagnostic catheterization.14 After coronary interventions, participant comfort is additionally increased by immediate sheath removal.
This early ambulation study is an evaluation of a clip-based technology, which achieves vascular hemostasis with the use of a novel extravascular Nitinol clip to provide an immediate mechanical closure that does not depend upon the body's clotting system. The procedures will be performed in participants who meet specific entrance criteria.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Vessel Closure (StarClose™) Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular, diagnostic catheterization procedures with the use of StarClose® Vascular Closure System in the femoral artery after diagnostic catheterization procedure.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Heart Care Midwest (OSF/St Francis)
🇺🇸Peoria, Illinois, United States
Bay Regional Medical Center
🇺🇸Bay City, Michigan, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
North Ohio Research LTD Elyria Regional Medical
🇺🇸Elyria, Ohio, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Fuqua Heart Center/ Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Drexel University College of Medicine Hahnemann
🇺🇸Philadelphia, Pennsylvania, United States
The Care Group LLC (St. Vincent's Hospital)
🇺🇸Indianapolis, Indiana, United States
Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Buffalo Heart group
🇺🇸Buffalo, New York, United States