OBJECTIVE: The RISE study was a prospective, multicenter, single-arm study evaluating the safety and efficacy of the StarClose Vascular Closure System (VCS) in the femoral artery in subjects who were ambulated early following percutaneous diagnostic coronary or peripheral catheterization procedures. BACKGROUND: Previous studies have demonstrated that several vascular closure devices are able to safely decrease the amount of bedrest needed following angiography. To date, no device has been shown to be safe for immediate ambulation. METHODS: Between April 2006 and November 2006, 315 patients undergoing a catheterization via the femoral artery were enrolled (intent-to-treat population, ITT). Of these, 171 subjects were not excluded by angiographic or clinical criteria and had a StarClose device placed to attain hemostasis. If hemostasis was immediately achieved, patients were ambulated within 20 min for 20 feet without assistance (per-protocol population, PP). Patients were followed for 30 days after the index procedure. The primary endpoint of the study was time to ambulation (TTA). RESULTS: Immediate hemostasis was achieved in 156 patients (91.2%). The mean TTA in the PP was 8.29 min, median 5.92. There were no deaths or major vascular complications, and the rate of minor vascular complications was 1.9% (3/156). CONCLUSION: The StarClose VCS device is both safe and effective allowing immediate ambulation of patients who have undergone catheterization via the femoral artery.
OBJECTIVE: The RISE study was a prospective, multicenter, single-arm study evaluating the safety and efficacy of the StarClose Vascular Closure System (VCS) in the femoral artery in subjects who were ambulated early following percutaneous diagnostic coronary or peripheral catheterization procedures. BACKGROUND: Previous studies have demonstrated that several vascular closure devices are able to safely decrease the amount of bedrest needed following angiography. To date, no device has been shown to be safe for immediate ambulation. METHODS: Between April 2006 and November 2006, 315 patients undergoing a catheterization via the femoral artery were enrolled (intent-to-treat population, ITT). Of these, 171 subjects were not excluded by angiographic or clinical criteria and had a StarClose device placed to attain hemostasis. If hemostasis was immediately achieved, patients were ambulated within 20 min for 20 feet without assistance (per-protocol population, PP). Patients were followed for 30 days after the index procedure. The primary endpoint of the study was time to ambulation (TTA). RESULTS: Immediate hemostasis was achieved in 156 patients (91.2%). The mean TTA in the PP was 8.29 min, median 5.92. There were no deaths or major vascular complications, and the rate of minor vascular complications was 1.9% (3/156). CONCLUSION: The StarClose VCS device is both safe and effective allowing immediate ambulation of patients who have undergone catheterization via the femoral artery.
Authors: Ammar Taha; Ellen K Walsh; Kathryn A Wright; Iftikhar Ahmed; Nucharin Supakul; Eric E Awwad; Juan G Tejada Journal: Interv Neuroradiol Date: 2013-09-26 Impact factor: 1.610
Authors: Scott L Zuckerman; Ritwik Bhatia; Crystiana Tsujiara; Christopher B Baker; Alex Szafran; Deborah Cushing; Judy Aiken; Marilyn Tracy; J Mocco; Robert D Ecker Journal: Interv Neuroradiol Date: 2015-02 Impact factor: 1.610
Authors: Aravind Sekhar; Brad S Sutton; Prafull Raheja; Amr Mohsen; Emily Anggelis; Chris N Anggelis; Matthew C Keith; Buddhadeb Dawn; Samantha Straton; Michael P Flaherty Journal: Int J Cardiol Heart Vasc Date: 2016-10-11