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Trial record 22 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

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

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ClinicalTrials.gov Identifier: NCT03816202
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

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.

Condition or disease Intervention/treatment
Carotid Artery Stenosis Device: Sundt carotid shunt

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Group/Cohort Intervention/treatment
Sundt Carotid Shunt
Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
Device: Sundt carotid shunt
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 Outcome Measures :
  1. Evidence of injury to the artery or cerebral ischemia secondary to shunt placement and removal [ Time Frame: up to 60 days post-procedure ]
    Evidence of injury to the artery or cerebral ischemia secondary to shunt placement and removal



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816202


Contacts
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Contact: Samira Lavingia, MBA 609-936-4682 samira.lavingia@integralife.com
Contact: Andrew Tummon 609-936-5490 andrew.tummon@gmail.com

Sponsors and Collaborators
Integra LifeSciences Corporation
Investigators
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Study Director: Andrew Tummon Integra LifeSciences

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Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT03816202     History of Changes
Other Study ID Numbers: C-SCS-001
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases