OPEN IN READ APP
JOURNAL ARTICLE
MULTICENTER STUDY

StarClose vascular closure system (VCS) is safe and effective in patients who ambulate early following successful femoral artery access closure—results from the RISE clinical trial

M Nicholas Burke, James Hermiller, Michael R Jaff
Catheterization and Cardiovascular Interventions 2012 July 1, 80 (1): 45-52
22162141

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.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Available on the App Store

Available on the Play Store
Remove bar
Read by QxMD icon Read
22162141
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"