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NCT03816202

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

Integra LifeSciences Corporation·ClinicalTrials.gov·device·Device trialCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Carotid Artery Stenosis
Drug/Device/Intervention
Sundt carotid shunt
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Integra LifeSciences Corporation
Location
Newburgh,Hackensack,New York, United States of America
Timeline & enrollment
Phase
N/A
Start date
Apr 25, 2019
End date
Aug 27, 2019
Enrollment
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 arteryCarotid artery syndrome (hemispheric)Injury of carotid arteryAneurysm and dissection of carotid arteryOcclusion and stenosis of vertebral artery
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03816202
Type
Device Trial
About this record

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.