ExoSeal® Vascular Closure Device is safe and effective
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April 1, 2008 By Alexandra M. Palmer [1]
SCAI-ACCi2 08-Chicago, IL: Results from the ECLIPSE trial demonstrate the superiority of the ExoSeal® Vascular Closure Device compared to manual compression in reducing both the time to hemostasis and the time to ambulation following intervention. The data was presented by Dr. Shing-Chiu Wong at the SCAI-ACC i2 summit Annual Scientific Sessions in Chicago today.
The goal of this trial was to compare the safety and efficacy of the 6 French ExoSeal® extra-vascular closure device versus manual compression (MC) following sheath removal. In the test for superiority, the primary endpoints were time to hemostasis (TTH) and time to ambulation (TTA). The primary safety endpoint tested for non-inferiority was the 30-day combined rate of ischemia, infection, injury at the puncture site requiring medical or surgical treatment or bleeding requiring transfusion.
The ECLIPSE (Ensure’s Vascular Closure Device Speeds Hemostasis) trial was a randomized, multicenter study which included patients undergoing diagnostic and interventional coronary/peripheral procedures at 17 U.S. centers. 401 patients were randomized to one of two methods for closing the femoral artery access site: ExoSeal® bioabsorbable plug (n = 267) or MC (n = 134). Follow-up time was 30 days.
Compared to standard manual compression, the ExoSeal® device was associated with a significant reduction in both TTH (4.4 ± 11.6 vs. 20.1 ± 22.5 minutes, p<0.0001) and TTA (2.5 ± 5.0 vs. 6.2 ± 13.3 hours p = 0.028). The test for non-inferiority was void as there were no complications in either study arm.
The investigators concluded that a significant reduction in the TTH and TTA (primary effectiveness endpoints) was achieved in patients treated with the investigational ExoSeal® device compared with standard manual compression. The device was successfully deployed in about 1 minute on average following the procedure. There was no difference in procedural success or 30 day combined access site related complications rates between the two groups.
Further studies will compare the patient comfort level following deployment of the ExoSeal® to other vascular closure devices. Other areas of interest include the device’s effectiveness in treating patients whose puncture sites lie at or below the branch point of the femoral and iliac arteries.
Sources
- Shing-Chiu Wong, Dennis Donohoe, Herbert Hutman, William Bachinsky, Patrick Cambier, Robert Stoler, Janah Aji, Jason Rogers, James Hermiller, Ravi Nair, Lee Jobe, Peter Casterella, John Lasala, David Roberts, Mike Fischi, Daniel McCormick, John Sweeny, Alan Yeung, Paul Huang. ECLIPSE Trial: Ensure’s Vascular Closure Device Speeds Hemostasis.
- Late Breaking Clinical Trials Session: SCAI Annual Scientific Sessions in partnership with ACC i2 summit, April 1, 2008 Chicago
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Some of the initial content on this page may be incorporated in part from copyleft sources in the public domain including wikis such as Wikipedia and AskDrWiki. Drug information for patients came from the The National Library of Medicine. Infectious disease information may have come from the Centers for Disease Control (CDC). Differential Diagnoses are drawn from clinicians as well as an amalgamation of 3 sources: 1.The Disease Database; 2. Kahan, Scott, Smith, Ellen G. In A Page: Signs and Symptoms. Malden, Massachusetts: Blackwell Publishing, 2004:3; 3. Sailer, Christian, Wasner, Susanne. Differential Diagnosis Pocket. Hermosa Beach, CA: Borm Bruckmeir Publishing LLC, 2002:7 .
