CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

NCT ID: NCT01569594

Last Updated: 2023-07-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2016-12-31

Brief Summary

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Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.

Detailed Description

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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.

Conditions

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Carotid Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elutia Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardio-Thoracic Surgeons, P.C. Trinity

Birmingham, Alabama, United States

Site Status

Vascular Surgical Associates P.C.

Marietta, Georgia, United States

Site Status

Cardiac Surgery Associates

Indianapolis, Indiana, United States

Site Status

St Luke's Hospital

Kansas City, Missouri, United States

Site Status

Cardiovascular Surgery Clinic, PLLC

Memphis, Tennessee, United States

Site Status

UVA Heart and Vascular Center

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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11-PR-1021

Identifier Type: -

Identifier Source: org_study_id

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