NCT07048067

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Carotid endarterectomy (CEA)	carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-04-30
• Completion: 2025-02-01
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study