Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: initial U.S. feasibility trial using the Duett vascular closure device.

The aim of this first U.S. feasibility study was to investigate the safety and efficacy of a novel vascular sealing device, Duett, following percutaneous endovascular procedures. Immediately following a catheterization procedure, the sealing device was deployed at the femoral arterial access site in 43 patients (diagnostic 29, intervention 11, intervention + abciximab 3). Patients were followed up at 1 month with clinical assessment, ankle-brachial index measurement, and Doppler ultrasound of the treated femoral artery puncture site. Successful hemostasis was achieved with the Duett alone in 42/43 (97.7%) patients. There was one uncomplicated crossover to manual compression. The time to hemostasis was 4.0+/-1.5, 6.9+/-4.2, and 5.8+/-1.2 min for diagnostic, interventional, and abciximab patients, respectively. At 1-month follow-up, one patient (2.3%) required ultrasound-guided compression for treatment of a pseudoaneurysm. There were no other major complications. This novel vascular sealing device appears to achieve rapid and safe hemostasis successfully immediately following a wide range of percutaneous endovascular procedures.

RCT Entities:   Population Interventions Outcomes