N/A
Completed N=230
CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
Source: ClinicalTrials.gov NCT01569594 ↗Enrolled (actual)
230
Serious AEs
11.3%
Results posted
Feb 2020
Primary outcomePrimary: Carotid Procedure and Device Related Adverse Events to Determine Device Performance — 53; 10; 1; 2 Device related adverse events
Summary
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Carotid Procedure and Device Related Adverse Events to Determine Device Performance |
53; 10; 1; 2 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01569594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.