Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Aortic Aneurysm, Abdominal Clinical Trial

— FENP  

Official title:

Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® and the Effects on Organ and Extremity Perfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652235
• Other study ID #: 07-003
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: September 26, 2023

Study information

• Verified date: December 2023
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 26, 2023
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter
• Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
• Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

• Age < 18 years
• Life expectancy < 2 years
• Pregnant or breast feeding
• Inability or refusal to give informed consent
• Unwilling or unable to comply with the follow-up schedule
• Additional medical restrictions as specified in the Clinical Investigation Plan
• Additional anatomical restrictions as specified in the Clinical Investigation Plan

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Locations

Country	Name	City	State
United States	Mount Sinai-West	New York	New York
United States	New York Presbyterian Hospital System	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate perfusion of visceral vessels	evaluate perfusion of visceral vessels (renal, mesenteric, and systemic)	up to 5 years