Presentation on theme: "ECLIPSE Trial: Ensure’s Vascular Closure Device Speeds Hemostasis S. Chiu Wong MD Director, Cardiac Catheterization Laboratories New York Presbyterian."— Presentation transcript:
ECLIPSE Trial: Ensure’s Vascular Closure Device Speeds Hemostasis S. Chiu Wong MD Director, Cardiac Catheterization Laboratories New York Presbyterian Hosp.- Cornell Campus Professor of Medicine Weill Medical College of Cornell University SCAI / ACCi2 2008 Late Breaking Trial April 2 nd Chicago, IL
ECLIPSE Trial Eclipse ® Closure Device The investigational ExoSeal device (Cordis, Miami FL) is a novel 3rd generation 6 Fr. extra- vascular closure device with a painless deployment mechanism that delivers a poly-glycolic acid (PGA) “felt-like” plug atop the femoral artery anchored by the neuro-vascular bundle sheath.
U.S. multicenter pivotal study comparing ExoSeal and manual compression with 2:1 randomization was performed to assess the safety and efficacy of ExoSeal in patients undergoing 6Fr. diagnostic and interventional coronary/peripheral procedures ECLIPSE Trial ECLIPSE Trial Design
Two primary effectiveness endpoints to be tested for superiority: –Time to hemostasis (TTH) –Time to ambulation (TTA) Primary safety endpoint to be tested for non- inferiority: –30-day combined rate of access site related complications including bleeding, infection, ischemia or injury requiring medical or surgical treatment ECLIPSE Trial Objectives
ECLIPSE Trial Patient Enrollment ExoSeal ® 6F VCD (17 U.S. Sites) N = 488 Randomized N = 401 Roll-in N = 87 ExoSeal ® (N=267)Mannual Compression (n=134) Withdrawn N = 10 (7.5%) 30-day FU N=253 ( 94.8%) 30-day FU N=124 (92.5%) Withdrawn N = 14 (5.2%) Withdrawn N = 5 (2.7%) 30 day FU N = 82 (94.3%)
ECLIPSE Trial Results: Primary 30-Day Safety Endpoints Roll-in (N=87) ExoSeal ® (N=266) MC (N=134) Composite Major Adverse Event0.0% Vascular Repair0.0% Access Site Related Bleeding Requiring Transfusion 0.0% Access Site Related Infection Requiring Treatment 0.0% Any New Documented Ipsilateral Lower Extremity Ischemia 0.0% Surgery for Access Site-Related Nerve Injury 0.0%
In this multi-center randomized trial in pts following 6 Fr. diagnostic/interventional procedures, a significant reduction in the TTH and TTA (primary effectiveness endpoints) was achieved in pts treated with the investigational ExoSeal device compared with MC Device deployment was achieved promptly in about 1 minute on average following procedure There was no difference in procedural success rates in both the ExoSeal ® and MC groups Remarkably, there were no 30-day combined access site related complications (primary safety endpoint) reported in either treatment cohort Exoseal is non-inferior to MC in composite major adverse event at the pre-specified 4% margin level Exoseal ® compares favorably to manual compression for arteriotomy site management post 6 Fr. invasive/interventional procedures. ECLIPSE Trial Conclusions