title: A multicenter randomized trial comparing the effectiveness and safety of a novel vascular closure device to manual compression in anticoagulated patients undergoing percutaneous transfemoral procedures: The CELT ACD trial.
abstract: OBJECTIVE
  This study compared the performance of Celt ACD®, a novel stainless steel based vascular closure device versus manual compression (MC) for femoral arteriotomy site hemostasis in patients undergoing percutaneous coronary procedures.
  
  
  BACKGROUND
  Optimal access site management after percutaneous transfemoral procedures remains controversial.
  
  
  METHODS
  Patients enrolled in this multicenter, randomized open label trial underwent 6-F diagnostic or interventional procedures and were assigned 2:1 to Celt ACD®versus MC. All patients were on full anticoagulation. The primary efficacy end point was time to hemostasis (TTH) and the primary safety end points were 30-day incidence of major procedural and access site related complications.
  
  
  RESULTS
  The trial allocated 207 patients to Celt ACD®(n = 148) versus MC (n = 59) at 5 investigational sites. Baseline characteristics of the two groups were similar. Median TTH was 0 (Interquartile range (IQR): 0, 0.33) in the Celt ACD®compared to 8 min (IQR: 0, 20; P < 0.0001) in the MC group. Procedural success was 99.3% in the Celt ACD®versus 98.1% in the MC group (P = NS). There was a single major adverse event due to device maldeployment and embolization with successful percutaneous retrieval. The 30-day major complication rate was 0.7% in the Celt ACD®and 0% in the MC group (P = NS).
  
  
  CONCLUSIONS
  After 6-F percutaneous invasive procedures in fully anticoagulated patients, TTH was significantly reduced in patients assigned to Celt ACD®compared to patients managed with MC. The 30-day rates of vascular complications were similarly low in both groups. (CELT ACD Trial; NCT01600482) © 2017 Wiley Periodicals, Inc.
authors.affiliation: Division of Cardiology, Department of Medicine, Weill Cornell Medical College/New York Presbyterian Hospital, New York, NY, USA.
authors.forename: Shing Chiu
authors.identifier: http://orcid.org/0000-0002-6064-5199
authors.initials: SC
authors.lastname: Wong
authors.affiliation: Charité Mitte (CCM), Berlin, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Laule
authors.affiliation: Rutgers Robert Wood Johnson Medical School, New Brunswick NJ USA & Cooper University Hospital, Camden, NJ, USA.
authors.forename: Zoltan
authors.identifier: http://orcid.org/0000-0002-4627-7828
authors.initials: Z
authors.lastname: Turi
authors.affiliation: Charité Mitte (CCM), Berlin, Germany.
authors.forename: Wasiem
authors.initials: W
authors.lastname: Sanad
authors.affiliation: University Hospital Galway, Galway, Ireland.
authors.forename: James
authors.initials: J
authors.lastname: Crowley
authors.affiliation: Medical Clinic, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.
authors.forename: Hubertus
authors.initials: H
authors.lastname: Degen
authors.affiliation: Department of Pharmacology & Therapeutics, Trinity College, St James's Hospital, Dublin, Ireland.
authors.forename: Kathleen
authors.initials: K
authors.lastname: Bennett
authors.affiliation: Vasorum Ltd. Dublin, Ireland.
authors.forename: Jim E
authors.initials: JE
authors.lastname: Coleman
authors.affiliation: Division of Cardiology, Department of Medicine, Weill Cornell Medical College/New York Presbyterian Hospital, New York, NY, USA.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Bergman
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000379:methods*; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000379:methods*; D057186:Comparative Effectiveness Research; D004867:Equipment Design; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006470:Hemorrhage / Q000139:chemically induced / Q000000981:diagnostic imaging / Q000517:prevention & control*; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000379:methods*; D011312:Pressure; D011446:Prospective Studies; D011677:Punctures; D012307:Risk Factors; D013193:Stainless Steel; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014481:United States; D065506:Vascular Closure Devices
chemical_list: D000925:Anticoagulants; D013193:Stainless Steel
keywords: interventional devices/innovation; percutaneous coronary intervention; vascular closure