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

Integra LifeSciences

Status: Completed

Conditions: Carotid Artery Stenosis

Treatments: Device: Sundt carotid shunt

Study type: Observational

Funder types: Industry

Identifiers

NCT03816202

C-SCS-001

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Sundt Carotid Shunt

Description:

Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.

Treatment:

Device: Sundt carotid shunt