Carotid Endarterectomy (CEA) Surgical PatientsVASCU-GUARDNCT07048067
Ultrasound Evaluation for Baxter VASCU-GUARD Vascular Patches Post-Endarterectomy and Complications Assessment
An observational study of Carotid Endarterectomy (CEA) Surgical Patients, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Endarterectomy (CEA) Surgical Patients
- What is being tested?
- Carotid endarterectomy (CEA)
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches in all campuses of the Houston Methodist Hospital
Who may be able to join
- Patients aged 18 years and above.
- Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches.
- Follow-up ultrasound assessment available
Who cannot join
- No postoperative ultrasound assessment is available.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Carotid endarterectomy (CEA)
- Keywords
- carotid endarterectomy (CEA), VASCU-GUARD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomy (CEA)Procedure or surgery
carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches | Follow-up ultrasound assessment available Receives: Procedure: Carotid endarterectomy (CEA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1/1/2023 - 4/30/2024
Secondary outcomes (2)
Complications assessment
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.
Measured: 1/1/2023 - 4/30/2024
Correlation with Clinical Outcomes
Recognize correlations between ultrasound findings and clinical outcomes. This correlation will complement the understanding of how ultrasound monitoring can predict and influence patient prognosis.
Measured: 1/1/2023 - 4/30/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Jan 2023
- Primary completion30 Apr 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Endarterectomy (CEA) Surgical PatientsStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahimi, Maham, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048067
- Sponsor's protocol ID
- 00038233
- Acronym
- VASCU-GUARD
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only study findings to be shared
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation for Baxter VASCU-GUARD Vascular Patches Post-Endarterectomy and Complications Assessment
- ClinicalTrials.gov ID
- NCT07048067
- Acronym / sponsor ID
- VASCU-GUARD / 00038233
- Keywords
- carotid endarterectomy (CEA), VASCU-GUARD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches | – | Procedure: Carotid endarterectomy (CEA)Follow-up ultrasound assessment available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches in all campuses of the Houston Methodist Hospital
Key inclusion criteria (3 listed)
- Patients aged 18 years and above.
- Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches.
- Follow-up ultrasound assessment available
Key exclusion criteria (1 listed)
- No postoperative ultrasound assessment is available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carotid endarterectomy (CEA)carotid endarterectomy (CEA) with the use of Baxter VASCU-GUARD vascular patches | Procedure or surgery | Patients undergoing carotid endarterectomy with the use of VASCU-GUARD vascular patches |
Primary outcome
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
2 secondary outcomes
Complications assessment
Time frame: 1/1/2023 - 4/30/2024
Correlation with Clinical Outcomes
Time frame: 1/1/2023 - 4/30/2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No. Only study findings to be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Endarterectomy (CEA) Surgical Patients, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound evaluation of Baxter VASCU-GUARD vascular patches (time frame: 1/1/2023 - 4/30/2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.