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J Interv Cardiol. 2012 Oct;25(5):518-25. doi: 10.1111/j.1540-8183.2012.00739.x. Epub 2012 Jul 5.

First-in-man experience with a new 7F vascular closure device (EXOSEAL™): the 7F ECLIPSE study.

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1
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany. marcus.wiemer@muehlenkreiskliniken.de

Abstract

OBJECTIVE:

This feasibility study examined safety and effectiveness of the new EXOSEAL™ Vascular Closure Device (VCD) designed to promote hemostasis and early ambulation after percutaneous procedures.

BACKGROUND:

Most VCDs currently approved by the United States FDA have been associated with significantly shorter time-to-hemostasis (TTH) and time-to-ambulation (TTA) compared to standard manual or mechanical compression, but their ease of use, patient comfort during deployment, and safety profiles are variable.

METHODS:

Patients underwent diagnostic or interventional procedures using 7F introducer sheaths. Primary safety endpoint was the 30-day combined rate of access-related complications and primary effectiveness endpoints were TTH and TTA.

RESULTS:

Sixty patients were enrolled prospectively (mean age 63.3 ± 11.3 year, 17% diabetics). Device and procedural success was achieved in 92% and 93%, respectively. Mean TTH and TTA was 3.2 ± 3.0 minutes and 3.0 ± 6.2 hours, respectively. No deaths or serious access-related adverse events occurred. A ≥6 cm access-site hematoma was the only adverse event, observed in 3 patients.

CONCLUSIONS:

Use of the 7F EXOSEAL™ VCD was associated with short TTH and TTA, as well as low rates of procedural and 30-day access-related complications.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00574691.

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