title: The StarClose Vascular Closure System: interventional results from the CLIP study.
abstract: BACKGROUND
  The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures.
  
  
  METHODS
  A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis.
  
  
  RESULTS
  The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different.
  
  
  CONCLUSIONS
  The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.
authors.affiliation: St. Vincent's Hospital, Indianapolis, Indiana, USA.
authors.forename: J B
authors.initials: JB
authors.lastname: Hermiller
authors.forename: C
authors.initials: C
authors.lastname: Simonton
authors.forename: T
authors.initials: T
authors.lastname: Hinohara
authors.forename: D
authors.initials: D
authors.lastname: Lee
authors.forename: L
authors.initials: L
authors.lastname: Cannon
authors.forename: M
authors.initials: M
authors.lastname: Mooney
authors.forename: C
authors.initials: C
authors.lastname: O'Shaughnessy
authors.forename: H
authors.initials: H
authors.lastname: Carlson
authors.forename: R
authors.initials: R
authors.lastname: Fortuna
authors.forename: M
authors.initials: M
authors.lastname: Zapien
authors.forename: D R
authors.initials: DR
authors.lastname: Fletcher
authors.forename: K
authors.initials: K
authors.lastname: DiDonato
authors.forename: T M
authors.initials: TM
authors.lastname: Chou
mesh_terms: D000368:Aged; D000497:Alloys; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005263:Femoral Artery / Q000601:surgery*; D005500:Follow-Up Studies; D006487:Hemostasis; D006489:Hemostatic Techniques / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology; D011446:Prospective Studies; D013525:Surgical Instruments / Q000009:adverse effects; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014652:Vascular Diseases / Q000453:epidemiology / Q000209:etiology
chemical_list: D000497:Alloys; C013616:nitinol