A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair

What this Trial Is About

Researchers are evaluating a physician modified endograft for treating complex aortic aneurysms, including pararenal, juxtarenal, and thoracoabdominal types, in high-risk patients who lack options for FDA-approved endovascular repair. This study focuses on patients with aneurysms involving visceral vessels such as the renal arteries, superior mesenteric artery, or celiac trunk. The purpose is to assess the safety and effectiveness of this device in a minimally invasive manner for those who cannot undergo traditional open repair. The treatment involves modifying Cook Medical devices, including Zenith TX2 Dissection Endovascular Grafts, Zenith Alpha Thoracic Endovascular Grafts, and Zenith Fenestrated Abdominal Aortic Aneurysm Endovascular Grafts. These devices are customized by creating fenestrations or branches to preserve blood flow to vital arteries. A staged approach may be used before device implantation to reduce risk. The modified graft is implanted using imaging guidance, and flow through the branches is ensured with selective angiograms. Participants will be followed for five years after enrollment, with visits at one month, six months, one year, and annually thereafter. Follow-up includes clinical exams, which may be conducted by phone or video, along with CT scans and ultrasounds as needed. Researchers will monitor safety by tracking major adverse events within 30 days or hospitalization and measure treatment success at one year and annually up to five years. Lifelong clinical follow-up will also be conducted to evaluate long-term outcomes.

Physician Modified Endograft For Complex Aortic Aneurysm Repair