- Zenith® Fenestrated+ Clinical Study — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT04875429.
- What is being tested: Safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) combined with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 for treating complex abdominal aortic aneurysms involving the renal and/or mesenteric arteries.
- Patient eligibility overview: Patients with juxtarenal or suprarenal abdominal aortic aneurysms requiring fenestrated endovascular repair, meeting specific anatomical criteria for aortic dimensions and vessel patency, and without contraindications to endovascular intervention or required imaging follow-up.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. Up to 60 additional subjects may be enrolled in Continued Access phase of the study
- Include Criteria: 1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females 2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months 3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter > 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.