CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
NCT ID: NCT01569594
Last Updated: 2023-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
230 participants
OBSERVATIONAL
2012-04-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Carotid Endarterectomy Subjects
Subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair
CorMatrix ECM for Carotid Repair
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
Interventions
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CorMatrix ECM for Carotid Repair
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Elutia Inc.
INDUSTRY
Responsible Party
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Locations
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Cardio-Thoracic Surgeons, P.C. Trinity
Birmingham, Alabama, United States
Vascular Surgical Associates P.C.
Marietta, Georgia, United States
Cardiac Surgery Associates
Indianapolis, Indiana, United States
St Luke's Hospital
Kansas City, Missouri, United States
Cardiovascular Surgery Clinic, PLLC
Memphis, Tennessee, United States
UVA Heart and Vascular Center
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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11-PR-1021
Identifier Type: -
Identifier Source: org_study_id
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