N/A
N=100
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
Carotid Artery Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT03816202 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal — 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sundt carotid shunt (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Integra LifeSciences Corporation
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal |
3 | — |
Summary
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03816202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.