Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
Completed
- Conditions
- Carotid Artery Stenosis
- Interventions
- Device: Sundt carotid shunt
- Registration Number
- NCT03816202
- Lead Sponsor
- Integra LifeSciences Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 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 Criteria
- Insertion of a carotid shunt at the site of an infection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sundt Carotid Shunt Sundt carotid shunt Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
- Primary Outcome Measures
Name Time Method Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal up to 60 days post-procedure Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Research Institute of Deaconess Clinic
🇺🇸Newburgh, Indiana, United States
The Mount Sinai Medical Center
🇺🇸New York, New York, United States
Hackensack Meridian Health
🇺🇸Hackensack, New Jersey, United States