At a glance
ClinicalIndex Comparison RecordN/ACompleted· 100 enrolled
Drug / intervention
Sundt carotid shuntdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
In Brief
An observational study evaluating Sundt carotid shunt for Carotid Artery Stenosis. Completed, enrolled 100 participants across 3 sites.
Detailed Summary
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCarotid Artery Stenosis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartApr 2019
Primary CompletionAug 2019
TodayJul 2026
First PostedJan 25, 2019
Enrollment StartApr 25, 2019
Primary CompletionAug 27, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.4 years ago
Interventions
Sundt carotid shuntdevice
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.