This trial is active, not recruiting.

Conditions aortic aneurysm, abdominal aortic aneurysm
Treatment endovascular treatment (zenith® p-branch™ endovascular graft)
Sponsor Cook
Start date June 2012
End date October 2015
Trial size 23 participants
Trial identifier NCT01663064, 11-018


The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Endovascular treatment
endovascular treatment (zenith® p-branch™ 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.

Primary Outcomes

Technical Success
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Pararenal or juxtarenal AAA >5.0 cm in diameter - Pararenal or juxtarenal AAA with history of growth >0.5 cm/year Exclusion Criteria: - Age < 18 years - Life expectancy < 2 years - Pregnant or breast feeding - 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 - Additional medical restrictions as specified in the Clinical Investigation Plan - Additional anatomical restrictions as specified in the Clinical Investigation Plan

Additional Information

Official title Zenith® p-Branch™: Single-Center Study
Principal investigator Timothy A. Resch, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Cook.