Physician Modified Endovascular Grafts for Abdominal Aortic Aneurysms
This study is testing Physician Modified Endovascular Grafts (PMEG) and a company-made device called Terumo Aortic Fenestrated TREO Endovascular Graft. These grafts are used to treat abdominal aortic aneurysms (a bulging in the main artery of the body). The goal is to see if these grafts are safe and effective for patients who have limited or no other treatment options. The study also aims to validate a 3-D printed template for surgical planning. We are looking for up to 500 participants, aged 18 and older, of all genders. Success will be measured by the safety and effectiveness of the grafts, and how well the procedure works, all within the first 12 months.
- Study design
- This is an interventional study planning to enroll up to 500 participants. The study is evaluating a device called Physician Modified Endovascular Grafts (PMEG) and the Terumo Aortic Fenestrated TREO Endovascular Graft.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and effectiveness for 12 months after the procedure.
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Physician Modified Endovascular Grafts
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Benjamin W Starnes, MD · PRINCIPAL_INVESTIGATOR · University of Washington
Who to contact
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What this trial measures
- Primary Safety EndpointsIndex Procedure through 12 Months
The safety of physician modified endovascular grafts will be determined by evaluating the proportion of patients that experience a rate of Major Adverse Events.
- Primary Effectiveness EndpointIndex Procedure through 12 Months
The primary effectiveness endpoint is the proportion of treatment group subjects that achieve technical and treatment success.
- Primary Technical Success EndpointIndex Procedure
Successful delivery and deployment of the investigational device with preservation of those branch vessels intended to be preserved at the study Index Procedure.
- Primary Treatment Success EndpointIndex Procedure through 12 Months
All the following composite endpoint criteria to be met in order for a patient to be considered a treatment success: Technical Success, Freedom from Type I \& III endoleak, Freedom from stent graft migration \>10mm, Freedom from AAA enlargement \>5mm, Freedom from AAA rupture, Freedom from surgical conversion to open repair