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Clinical Trials/NCT03816202
NCT03816202
Completed
Not Applicable

Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)

Integra LifeSciences Corporation3 sites in 1 country100 target enrollmentApril 25, 2019
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ConditionsCarotid Artery Stenosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Artery Stenosis
Sponsor
Integra LifeSciences Corporation
Enrollment
100
Locations
3
Primary Endpoint
Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 25, 2019
End Date
August 27, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal

Time Frame: up to 60 days post-procedure

Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal

Study Sites (3)

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