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OpenTrials
Completed

NCT Number: NCT01569594

CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

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

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Key information

Conditions

Carotid Stenosis Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardio-Thoracic Surgeons, P.C. Trinity, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CorMatrix ECM for Carotid Repair

Device

Subjects must be undergoing carotid endarterectomy with patch angioplasty closure

Primary outcomes

  1. Carotid Procedure and Device Related Adverse Events to Determine Device Performance

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Elutia Inc.

Industry

Registry information

Official study title

CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2012
Registry last updated
Jul 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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