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

Catheter Cardiovasc Interv. 2017 Nov 1;90(5):756-765. doi: 10.1002/ccd.26991. Epub 2017 Mar 15.


Objectives: 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.

Keywords: interventional devices/innovation; percutaneous coronary intervention; vascular closure.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Anticoagulants / adverse effects
  • Anticoagulants / therapeutic use*
  • Cardiac Catheterization / adverse effects
  • Cardiac Catheterization / methods*
  • Catheterization, Peripheral / adverse effects
  • Catheterization, Peripheral / methods*
  • Comparative Effectiveness Research
  • Equipment Design
  • Europe
  • Female
  • Femoral Artery* / diagnostic imaging
  • Hemorrhage / chemically induced
  • Hemorrhage / diagnostic imaging
  • Hemorrhage / prevention & control*
  • Hemostatic Techniques / adverse effects
  • Hemostatic Techniques / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / methods*
  • Pressure
  • Prospective Studies
  • Punctures
  • Risk Factors
  • Stainless Steel
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Doppler, Color
  • United States
  • Vascular Closure Devices*


  • Anticoagulants
  • Stainless Steel

Associated data

  • ClinicalTrials.gov/NCT01600482