Zenith® Fenestrated+ Clinical Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCook Research Incorporated

About this trial

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

Eligibility criteria

Qualifiers

Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females

Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months

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

Disqualifiers

Age < 18 years

Life expectancy < 2 years

Pregnant, breast-feeding, or planning to become pregnant within 60 months

Inability or refusal to give informed consent by the patient or legally authorized representative

Trial design

Treatments tested in this trial

  • Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2

Treatment groups

105 Participants
are divided into 1 treatment group

Sponsors and collaborators