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NCT03816202 Clinical Trial

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

Carotid Artery Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03816202
Other study ID # C-SCS-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 25, 2019
Est. completion date August 27, 2019

Study information
Verified date January 2022
Source Integra LifeSciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 27, 2019
Est. primary completion date August 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Sundt carotid shunt
The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.

Locations
Country Name City State
United States Hackensack Meridian Health Hackensack New Jersey
United States The Mount Sinai Medical Center New York New York
United States Research Institute of Deaconess Clinic Newburgh Indiana

Sponsors (1)
Lead Sponsor Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal up to 60 days post-procedure
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