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Completed

NCT Number: NCT07048067

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

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.

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Key information

Conditions

Carotid Endarterectomy (CEA) Surgical Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carotid endarterectomy (CEA)

Procedure

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

Primary outcomes

  1. 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

  1. Complications assessment

    Time frame: 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.

  2. Correlation with Clinical Outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Acronym: VASCU-GUARD

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 2, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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