title: 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.
abstract: 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).
  
  
  CONCLUSIONS
  The StarClose VCS device is both safe and effective allowing immediate ambulation of patients who have undergone catheterization via the femoral artery.
authors.affiliation: Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA. nburke@mplsheart.com
authors.forename: M Nicholas
authors.initials: MN
authors.lastname: Burke
authors.forename: James
authors.initials: J
authors.lastname: Hermiller
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000379:methods; D004434:Early Ambulation; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011677:Punctures; D011859:Radiography; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult