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No phaseRecruitingAge-related condition

Zenith® Fenestrated+ Clinical Study

Zenith® Fenestrated+ Endovascular Graft Clinical Study

Sponsor
Cook Research Incorporated (Industry)
Enrolment
105 planned
Conditions
Aortic Aneurysm, Abdominal; Juxtarenal Aortic Aneurysm; Extent IV Thoracoabdominal; Pararenal Aneurysm
Interventions
Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
Ages
adults, older adults
Registry
NCT04875429

Full record on ClinicalTrials.gov

From the registry

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 130 additional subjects may be enrolled in Continued Access phase of the study

Primary outcomes

  • Composite measure of device technical success and procedural safety
  • Composite measure of freedom from aneurysm-related mortality and clinically significant reintervention

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered