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.

Completed

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Institute of Deaconess Clinic, Newburgh, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal

Time frame: up to 60 days post-procedure

Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Jan 25, 2019
Registry last updated: Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed