Jan, A; Büllesfeld, Lutz; Coleman, J; Grube, E; Mulvihill, N (2013). First Clinical Experience With Celt ACD(®) : A Femoral Arterial Puncture Closure Device. Journal of interventional cardiology, 26(4), pp. 417-424. Wiley 10.1111/joic.12046
Full text not available from this repository. (Request a copy)Introduction
This prospective nonrandomized study compared the safety and efficacy of a novel arterial closure device (ACD) in common femoral artery procedures to that of the FDA submitted historical manual pressure control group, who underwent either a diagnostic angiogram (DA) or a percutaneous coronary intervention (PCI) procedure.
Methods and Results
A total of 55 patients were enrolled in this study of the novel ACD. Of the 55 patients, 39 were enrolled in the DA group and 16 were enrolled in the PCI group. Six patients were excluded. A device was deployed in 49 patients. Time to hemostasis (TTH), time to ambulation (TTA), device function, and device-related vascular complications were measured. In the device group, the TTH for the combined DA and PCI patients was 32 seconds (0.54 ± 0.93 minutes), significantly lower when compared with 16.0 ± 12.2 minutes (P < 0.0001) for the control group. Overall major vascular complication rate did not differ significantly, device group (1/49) and the historical control group (1/217). TTA in the combined PCI and DA device group was 226.4 ± 231.9 at the German site (site ambulation policy). In the Irish site, the average TTA in the PCI group was 187 minutes (n = 8) and 85 minutes (n = 14) in the DA group.
Conclusion
The Celt ACD® device is safe, effective, and significantly decreases the TTH compared to manual pressure and has a low vascular complications rate. The device may be effective in early ambulation and discharge of patients postcoronary intervention procedures.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology |
UniBE Contributor: |
Büllesfeld, Lutz |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
0896-4327 |
Publisher: |
Wiley |
Language: |
English |
Submitter: |
Lutz Büllesfeld |
Date Deposited: |
24 Mar 2014 11:04 |
Last Modified: |
05 Dec 2022 14:31 |
Publisher DOI: |
10.1111/joic.12046 |
URI: |
https://boris.unibe.ch/id/eprint/47464 |
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