NCT00736086

RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System

A Post-Market, Prospective, Multi-Center, Study to Evaluate Safety and Efficacy of the StarClose™ Vascular Closure System in Patients Who Are Ambulated Early Post-Diagnostic Catheterization

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 165 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Vascular Disease
• Cardiovascular Disease

Interventions

Type	Name	Description
DEVICE	Vessel Closure (StarClose™)

Timeline

• Start date: 2006-03-01
• Primary completion: 2006-11-01
• Completion: 2006-12-01
• First posted: 2008-08-15
• Last updated: 2008-08-15

Locations

11 sites across 1 country: United States