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Device
Sundt Carotid Shunt for Carotid Artery Stenosis
N/A
Waitlist Available
Research Sponsored by Integra LifeSciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 days post-procedure
Awards & highlights
No Placebo-Only Group
Summary
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
Eligible Conditions
- Carotid Artery Stenosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 days post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 days post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sundt Carotid ShuntExperimental Treatment1 Intervention
Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sundt carotid shunt
2019
N/A
~100
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Who is running the clinical trial?
Integra LifeSciences CorporationLead Sponsor
108 Previous Clinical Trials
11,194 Total Patients Enrolled
Andrew TummonStudy DirectorIntegra LifeSciences
6 Previous Clinical Trials
624 Total Patients Enrolled
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