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

Integra LifeSciences Corporation100 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Carotid Artery Stenosis

Interventions

Sundt carotid shuntDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

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

Time frame: up to 60 days post-procedure

Data from ClinicalTrials.gov

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