Ultrasound Evaluation for Baxter VASCU-GUARD Vascular Patches Post-Endarterectomy and Complications Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Ultrasound evaluation of Baxter VASCU-GUARD vascular patches
Study Overview
Brief Summary
VASCU-GUARD vascular patches with the new packaging have been available at the Houston Methodist Hospital since January 2023. This study is a retrospective chart review, aiming to compare the performance of Baxter VASCU-GUARD vascular patches implemented during carotid endarterectomies (CEA) prior to January 2023 and after January 2023. This study is one of a kind, as no other comparative retrospective chart review on the performance of VASCU-GUARD vascular patches from the old and new packaging has been published yet.
The project will contribute to the scientific knowledge about long-term outcomes associated with the use of patch material during endarterectomies.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 years and above.
- •Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches.
- •Follow-up ultrasound assessment available
Exclusion Criteria
- •No postoperative ultrasound assessment is available.
Outcomes
Primary Outcomes
Ultrasound evaluation of Baxter VASCU-GUARD vascular patches
Time Frame: 1/1/2023 - 4/30/2024
Retrospective review of ultrasound recordings and ultrasound reports at one-month, 3-months, 6-months and 1-year follow-up after endarterectomy - if available, to evaluate patch patency, morphology, integrity, complications, and blood flow dynamics
Secondary Outcomes
- Complications assessment(1/1/2023 - 4/30/2024)
- Correlation with Clinical Outcomes(1/1/2023 - 4/30/2024)
Investigators
Rahimi, Maham
Associate Professor of Cardiovascular Surgery
The Methodist Hospital Research Institute