First-in-man experience with a new 7F vascular closure device (EXOSEAL™): the 7F ECLIPSE study
Marcus Wiemer, Christoph Langer, Stephan Fichtlscherer, Christian Firschke, Florian Hofbauer, Markus Lins, Michael Haude, Christof Debèfve, Hans-Peter Stoll, Christoph Hanefeld, Marcus Wiemer, Christoph Langer, Stephan Fichtlscherer, Christian Firschke, Florian Hofbauer, Markus Lins, Michael Haude, Christof Debèfve, Hans-Peter Stoll, Christoph Hanefeld
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.
©2012, Wiley Periodicals, Inc.
Source: PubMed