Zenith® Fenestrated+ Clinical Study for Aortic Aneurysms
This study is testing a new way to treat aortic aneurysms (a bulging in the body's main artery) that involve major arteries to your organs. It uses a device called the Zenith® Fenestrated+ Endovascular Graft, along with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2. The study aims to see how safe and effective this treatment is. You might be able to join if you have a specific type of aortic aneurysm that is at least 55mm (for males) or 50mm (for females), or if it's growing quickly, or is more than twice the normal size. Researchers will measure if the device works as intended and is safe after 30 days, and if it prevents aneurysm-related deaths and serious re-interventions after 12 months. The study plans to enroll 105 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 105 participants, with up to 60 more in a continued access phase.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will follow participants for at least 12 months after the procedure to assess long-term safety and effectiveness.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Zenith® Fenestrated+ Clinical Study
At a glance
Conditions
Where it's being run
33 sites across 22 statesStudy leadership
- Gustavo Oderich, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
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What this trial measures
- Composite measure of device technical success and procedural safety30 days post procedure
Percent of patients with device technical success and freedom from procedural safety events in the following criteria: 1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and 2. Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
- Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention12 months post procedure
Percent of patients meeting the following criteria: 1. Freedom from aneurysm-related mortality (death from aneurysm rupture, death from any cause occurring within 30 days of procedure or secondary intervention or device or procedure related death) and 2. Freedom from clinically significant reintervention (including open surgery to restore blood flow or restore bodily function, any device related intervention requiring hospitalization, placement of an additional endovascular graft component(s), placement of a stent(s) as indicated for loss of or for having inadequate fixation, seal or patency)