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

NCT03816202 | Completed Results FDA Device

• 1 other identifier: C-SCS-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Carotid Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Sundt Carotid Shunt

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

Device: Sundt carotid shunt

Interventions

Sundt carotid shunt DEVICE

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.

Sundt Carotid Shunt

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (3)

Research Institute of Deaconess Clinic

Newburgh, Indiana, 47630, United States

Location

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

The Mount Sinai Medical Center

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Andrew Tummon, Director, Global Clinical Trials
• Organization: Integra LifeSciences

andrew.tummon@integralife.com

609-936-5490

Study Officials

• Andrew Tummon

  Integra LifeSciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: April 25, 2019
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)