ZFEN + Clinical Study
Research type
Research Study
Full title
Zenith® Fenestrated+ Endovascular Graft (ZFEN+) Clinical Study
IRAS ID
287152
Contact name
Bijan Modarai
Contact email
Sponsor organisation
Cook Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 6 months, 1 days
Research summary
This study is designed to assess the effects of the Zenith® Fenestrated+ (ZFEN+) endovascular graft in combination with the BeGraft® Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and if necessary, the Zenith Universal Distal Body 2.0 Endovascular Graft (Unibody2) and Zenith Spiral-Z AAA Iliac Leg Graft (ZSLE) on abdominal aortic aneurysms (a bulge in the abdomen´s main blood vessel that supplies blood to most of the lower body, including major organ sand the legs). A graft is a tube that makes a new path through the aneurysm to allow blood to flow safely through the aneurysm. The graft contains fenestrations (holes) that allow blood flow into the arteries branching off the aorta: the renal arteries supplying the kidneys), superior mesenteric artery (supplying the intestine and the pancreas), and the celiac artery (supplying the liver, esophagus, and stomach). To ensure the blood flow from the graft holes to these arteries, a BeGraft is used to “bridge” between the ZFEN+ fenestrations and the targeted artery. Data from patients treated with the study devices will be obtained (prospectively) in up to 35 hospitals in multiple countries.
The study will include at least 102 patients (at most 122 patients) to be followed for 5 years. All included patients will receive the same treatment (non-randomized).
Main objectives of the study are:
- To assess the safety of the devices through 30 days: percent of patients with successful implantation of study devices with freedom from any unplanned additional procedures or procedural safety events.
- To assess the effectiveness of the devices through 12 months: percent of patients with freedom from aneurysm-related death or significant clinical interventions to correct issues with study devices following the procedure.
The study’s secondary objectives will assess other relevant measurements of device performance throughout study follow-up.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0271
Date of REC Opinion
4 Nov 2024
REC opinion
Further Information Favourable Opinion