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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-25

Study Completion Date

2019-08-27

Brief Summary

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

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Detailed Description

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Conditions

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Carotid Artery Stenosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sundt Carotid Shunt

Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.

Sundt carotid shunt

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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