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

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

Study Overview

• Status: Completed
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Device: Sundt carotid shunt

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Research Institute of Deaconess Clinic
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Health
  • New York
    • New York, New York, United States, 10029
      • The Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects participating in the study have undergone a carotid endarterectomy procedure with the use of the Sundt™ carotid shunt prior to study initiation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sundt Carotid Shunt; Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): August 27, 2019
• Study Completion (Actual): August 27, 2019

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: C-SCS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No