Trials / Completed
CompletedNCT03816202
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-04-25
- Primary completion
- 2019-08-27
- Completion
- 2019-08-27
- First posted
- 2019-01-25
- Last updated
- 2022-01-14
- Results posted
- 2022-01-14
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03816202. Inclusion in this directory is not an endorsement.