CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/30/2017 |
| Start Date: | April 2012 |
| End Date: | December 31, 2016 |
CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry
The objective of this registry is to capture and assess device performance data from
subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy
using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This
registry provides an ongoing post-market surveillance mechanism to document clinical
outcomes on the use of the CorMatrix ECM for Carotid Repair.
subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy
using the CorMatrix ECM for Carotid Repair per its FDA cleared Indications for Use. This
registry provides an ongoing post-market surveillance mechanism to document clinical
outcomes on the use of the CorMatrix ECM for Carotid Repair.
Inclusion Criteria:
- Subjects must be undergoing carotid endarterectomy with patch angioplasty closure.
- Subject's operative surgeon intends to use CorMatrix ECM as the patch material for
closure of the carotid artery per its FDA cleared Indications for Use.
- The subject must possess the ability to provide written Informed Consent.
- The subject must express an understanding and willingness to fulfill all of the
expected requirements of this clinical protocol.
Exclusion Criteria:
- Subjects with a known sensitivity to porcine material.
We found this trial at
6
sites
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