NCT04875429

Zenith® Fenestrated+ Clinical Study

Zenith® Fenestrated+ Endovascular Graft Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Aortic Aneurysm, Abdominal
• Juxtarenal Aortic Aneurysm
• Extent IV Thoracoabdominal
• Pararenal Aneurysm

Interventions

Type	Name	Description
DEVICE	Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2	Endovascular aneurysm repair

Timeline

• Start date: 2023-12-08
• Primary completion: 2026-11-01
• Completion: 2031-11-01
• First posted: 2021-05-06
• Last updated: 2026-03-23

Locations

33 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study