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

Sponsor

Cook Research Incorporated (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01652235

Collaborator

(none)

Enrollment

Locations

Arm

187

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Abdominal	Device: Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2008

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endovascular Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft	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. Other Names: Endovascular stent Stent-graft

Arm

Intervention/Treatment

Experimental: Endovascular

Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft

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.

Other Names:

Endovascular stent

Stent-graft

Outcome Measures

Primary Outcome Measures

evaluate perfusion of visceral vessels [up to 5 years]
evaluate perfusion of visceral vessels (renal, mesenteric, and systemic)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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