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

NCT07048067 | Completed FDA Device

• 1 other identifier: 00038233
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Endarterectomy (CEA) Surgical Patients

Keywords

carotid endarterectomy (CEA); VASCU-GUARD

Outcome Measures

Primary Outcomes (1)

• Ultrasound evaluation of Baxter VASCU-GUARD vascular patches

  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

  1/1/2023 - 4/30/2024

Secondary Outcomes (2)

• Complications assessment

  1/1/2023 - 4/30/2024

• Correlation with Clinical Outcomes

  1/1/2023 - 4/30/2024

Study Arms (1)

Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches

Follow-up ultrasound assessment available

Procedure: Carotid endarterectomy (CEA)

Interventions

Carotid endarterectomy (CEA) PROCEDURE

carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches

Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches in all campuses of the Houston Methodist Hospital

You may qualify if:

• Patients aged 18 years and above.
• Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches.
• Follow-up ultrasound assessment available

You may not qualify if:

• No postoperative ultrasound assessment is available.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Endarterectomy, Carotid

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiovascular Surgery

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: January 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: February 1, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)