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ECLIPSE Trial: E nsure’s Vas c ular C l osure Dev i ce S p eed s H e mostasis

ECLIPSE Trial: E nsure’s Vas c ular C l osure Dev i ce S p eed s H e mostasis. S. Chiu Wong MD Director, Cardiac Catheterization Laboratories New York Presbyterian Hosp.- Cornell Campus Professor of Medicine Weill Medical College of Cornell University.

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ECLIPSE Trial: E nsure’s Vas c ular C l osure Dev i ce S p eed s H e mostasis

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  1. 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 TrialApril 2nd Chicago, IL

  2. ECLIPSE TrialEclipse® 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.

  3. ECLIPSE Trial ECLIPSE Trial Design • 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

  4. ECLIPSE Trial Objectives • 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

  5. ECLIPSE Trial Patient Enrollment ExoSeal® 6F VCD (17 U.S. Sites)N = 488 Roll-in N = 87 Withdrawn N = 5 (2.7%) Randomized N = 401 30 day FU N = 82 (94.3%) ExoSeal® (N=267) Mannual Compression (n=134) Withdrawn N = 14 (5.2%) Withdrawn N = 10 (7.5%) 30-day FU N=253 ( 94.8%) 30-day FU N=124 (92.5%)

  6. ECLIPSE Trial Results: Primary Effectiveness Endpoints

  7. ECLIPSE Trial Results: Primary 30-Day Safety Endpoints zero!

  8. ECLIPSE Trial Conclusions • 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 no30-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.

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