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Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF) - Trial NCT03816202

Access comprehensive clinical trial information for NCT03816202 through Pure Global AI's free database. This phase not specified trial is sponsored by Integra LifeSciences Corporation and is currently Completed. The study focuses on Carotid Artery Stenosis. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT03816202
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Trial Details
ClinicalTrials.govNCT03816202
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Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)

Study Focus

Carotid Artery Stenosis

Sundt carotid shunt

Observational

device

Sponsor & Location

Integra LifeSciences Corporation

Newburgh,Hackensack,New York, United States of America

Timeline & Enrollment

N/A

Apr 25, 2019

Aug 27, 2019

100 participants

Primary Outcome

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

Summary

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

ICD-10 Classifications

Occlusion and stenosis of carotid artery
Carotid artery syndrome (hemispheric)
Injury of carotid artery
Aneurysm and dissection of carotid artery
Occlusion and stenosis of vertebral artery

Data Source

ClinicalTrials.gov

NCT03816202

Device Trial