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

Completed

• Conditions: Carotid Endarterectomy (CEA) Surgical Patients

• Registration Number: NCT07048067
• Lead Sponsor: The Methodist Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-04-30
• Study Completion: 2025-02-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound evaluation of Baxter VASCU-GUARD vascular patches	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 Outcome Measures

Name	Time	Method
Complications assessment	1/1/2023 - 4/30/2024	Analyze complications linked with Baxter Vascular Patches (VASCU-GUARD), including but not limited to thrombosis, stroke, dissection, restenosis, infection, fluid collection, pseudoaneurysm formation, fraying or irregularities in patch material.
Correlation with Clinical Outcomes	1/1/2023 - 4/30/2024	Recognize correlations between ultrasound findings and clinical outcomes. This correlation will complement the understanding of how ultrasound monitoring can predict and influence patient prognosis.

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States