Zenith® p-Branch® Endovascular Graft Pivotal Study

Cook Group

Status

Completed

Conditions

Aortic Aneurysm Abdominal

Treatments

Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents

Study type

Interventional

Funder types

Industry

Identifiers

NCT02396199

14-09

Details and patient eligibility

About

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation

Exclusion criteria

Age <18 years
Life expectancy <2 years
Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
Inability or refusal to give informed consent by the patient or a legally authorized representative
Unwilling or unable to comply with the follow-up schedule
Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
Additional medical restrictions as specified in the Clinical Investigation Plan
Additional anatomical restrictions as specified in the Clinical Investigation Plan