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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. 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

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

eclipse trial eclipse closure device
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.
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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
slide4
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
slide5
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Withdrawn N = 5 (2.7%)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Withdrawn N = 14 (5.2%)

Withdrawn N = 10 (7.5%)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%)

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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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