NCT04875429

Zenith® Fenestrated+ Clinical Study

Official Title:

Zenith® Fenestrated+ Endovascular Graft Clinical Study

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.

Eligibility

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

Disease(s) and\or Condition(s)

Aortic Aneurysm, Abdominal

Juxtarenal Aortic Aneurysm

Extent IV Thoracoabdominal

Pararenal Aneurysm

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DEVICE
    • Name: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
    • Description: Endovascular aneurysm repair
    • Arm Group Labels: Aortic abdominal aneurysm
Sponsor
  • Cook Research Incorporated