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CorMatrix ECM for Carotid Repair Following Endarterectomy Registry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by CorMatrix Cardiovascular, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
CorMatrix Cardiovascular, Inc.
ClinicalTrials.gov Identifier:
NCT01569594
First received: March 30, 2012
Last updated: May 6, 2014
Last verified: May 2014
  Purpose
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.

Condition Intervention
Carotid Stenosis
Device: CorMatrix ECM for Carotid Repair

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CorMatrix® ECM® for Carotid Repair Following Endarterectomy Registry

Further study details as provided by CorMatrix Cardiovascular, Inc.:

Primary Outcome Measures:
  • Carotid procedure and device related adverse events to determine device performance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Carotid procedure and device related adverse events to determine device performance


Estimated Enrollment: 230
Study Start Date: April 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Carotid Endarterectomy Subjects Device: CorMatrix ECM for Carotid Repair
Subjects must be undergoing carotid endarterectomy with patch angioplasty closure

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 230 subjects may be enrolled from up to ten U.S. clinical sites
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569594

Locations
United States, Alabama
Cardio-Thoracic Surgeons, P.C. Trinity
Birmingham, Alabama, United States, 35243
United States, Georgia
Vascular Surgical Associates P.C.
Marietta, Georgia, United States, 30060
United States, Indiana
Cardiac Surgery Associates
Indianapolis, Indiana, United States, 46237
United States, Missouri
St Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, Tennessee
Cardiovascular Surgery Clinic, PLLC
Memphis, Tennessee, United States, 38120
United States, Virginia
UVA Heart and Vascular Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
CorMatrix Cardiovascular, Inc.
  More Information

Responsible Party: CorMatrix Cardiovascular, Inc.
ClinicalTrials.gov Identifier: NCT01569594     History of Changes
Other Study ID Numbers: 11-PR-1021 
Study First Received: March 30, 2012
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016