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Clinical Trials/NCT07048067
NCT07048067CompletedNot Applicable

Ultrasound Evaluation for Baxter VASCU-GUARD Vascular Patches Post-Endarterectomy and Complications Assessment

The Methodist Hospital Research Institute1 site in 1 country500 target enrollmentStarted: January 1, 2023Last updated:

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rahimi, Maham

Associate Professor of Cardiovascular Surgery

The Methodist Hospital Research Institute

Study Sites (1)

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