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.

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.