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A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: The ECLIPSE (Ensures Vascular Closure Device Speeds Hemostasis Trial)
JACC - Journal of the American College of Cardiology: Cardiovascular Interventions, 08/20/09
Wong SC et al. – After 6-F percutaneous invasive procedures, both time to hemostasis (TTH) and time to ambulation (TTA) were significantly shorter in pts assigned to a novel bioabsorbable vascular closure device (VCD) vs management with manual compression (MC). The 30-day rates of access-site-related complications were remarkably low in all groups.
Methods- Multicenter, nonblinded trial to compare performance of a bioabsorbable VCD vs MC for access site hemostasis in pts undergoing percutaneous transfemoral coronary or peripheral procedures
- Randomization for 6-Fr diagnostic or interventional procedures 2:1 to VCD vs MC
- Primary efficacy endpoints: TTH and TTA
- Primary safety endpoints: periprocedural and 30-day incidence of arterial access-related complications
- At 17 institutions, 401 pts (mean age 62.7 ± 10.9 yrs, 66.1% men) to VCD (267) vs MC (134) after 87 "roll-in" pts treated
- Similar baseline characteristics for both groups
- Procedural success: 91.8% in the VCD vs 91.0% in MC group
- Mean TTH: 4.4 ± 11.6 min in VCD v 20.1 ± 22.5 min in MC group
- TTA significantly shorter in VCD (2.5 ± 5.0 hr) vs MC (6.2 ± 13.3 hr)
- No pt died or had major access-site-related adverse event
- Minor adverse events few among all study groups
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