Zenith® Fenestrated+ Clinical Study

Study on Safety and Effectiveness of a Graft for Aortic Aneurysms

Recruiting
18 years or above
All
Phase N/A
105 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm
  • Age: 18 years or above
  • Gender: All

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

Exclusion Criteria:

  1. Age < 18 years
  2. Life expectancy < 2 years
  3. Pregnant, breast-feeding, or planning to become pregnant within 60 months
  4. Inability or refusal to give informed consent by the patient or legally authorized representative
  5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging
  6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study

This study investigates the safety and effectiveness of an investigational endovascular graft system for treating aortic aneurysms. These aneurysms can involve one or more of the major visceral arteries, which supply blood to essential organs.

Participants in the study will receive a combination of an investigational endovascular graft and other stent systems. The study will monitor the outcomes of these procedures to assess their safety and effectiveness in managing the aneurysms.

  • Who can participate: Adults aged 18 and older with thoracoabdominal, pararenal, or juxtarenal aortic aneurysms may participate. Key eligibility includes aneurysms with a diameter of 55 mm or more for males and 50 mm or more for females, or those with a growth rate of 5 mm in 6 months.
  • Study details: Participants will receive an investigational endovascular graft system combined with additional stent systems to treat their aortic aneurysms.
Updated on 23 Mar 2026. Study ID: 24-0066

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