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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07048067
Acronym
VASCU-GUARD
Enrollment
500
Registered
2025-07-02
Start date
2023-01-01
Completion date
2025-02-01
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Endarterectomy (CEA) Surgical Patients

Keywords

carotid endarterectomy (CEA), VASCU-GUARD

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.

Interventions

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

Sponsors

The Methodist Hospital Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound evaluation of Baxter VASCU-GUARD vascular patches1/1/2023 - 4/30/2024Retrospective 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

MeasureTime frameDescription
Complications assessment1/1/2023 - 4/30/2024Analyze 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 Outcomes1/1/2023 - 4/30/2024Recognize correlations between ultrasound findings and clinical outcomes. This correlation will complement the understanding of how ultrasound monitoring can predict and influence patient prognosis.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026