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

NCT ID: NCT07048067

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-02-01

Brief Summary

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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

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Conditions

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Carotid Endarterectomy (CEA) Surgical Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

Follow-up ultrasound assessment available

Carotid endarterectomy (CEA)

Intervention Type PROCEDURE

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

Interventions

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Carotid endarterectomy (CEA)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Rahimi, Maham

Associate Professor of Cardiovascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Houston Methodist Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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00038233

Identifier Type: -

Identifier Source: org_study_id

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