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

Completed

Conditions studied: Carotid Artery Stenosis

In brief

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

Key facts

Study ID

NCT03816202

Run by

Integra LifeSciences Corporation

People needed

100

Starts

2019-04-25

Expected to finish

2019-08-27

Last updated by the study team

2022-01-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Insertion of a carotid shunt at the site of an infection

Where it is running

• Research Institute of Deaconess Clinic — Newburgh, Indiana, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States
• The Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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