Status:
COMPLETED
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Carotid Artery Stenosis
Eligibility:
All Genders
18-80 years
Brief Summary
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
Eligibility Criteria
Inclusion
- Between the ages of 18-80 years old
- Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or before date of study initiation
- Availability of records on post-operative imaging of the carotid artery either by carotid duplex ultrasound or angiogram
Exclusion
- Insertion of a carotid shunt at the site of an infection
Key Trial Info
Start Date :
April 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 27 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03816202
Start Date
April 25 2019
End Date
August 27 2019
Last Update
January 14 2022
Active Locations (3)
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1
Research Institute of Deaconess Clinic
Newburgh, Indiana, United States, 47630
2
Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
3
The Mount Sinai Medical Center
New York, New York, United States, 10029