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

N = 148

Fully anti-coagulated
patients

99.3%

Procedural
success

Rapid Hemostasis

Mean TTH = 1.0 min
Median TTH = 0.0 min

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 5 148) versus MC (n 5 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 5 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 5 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)