Brief Title
Zenith® p-Branch™: Single-Center Study
Official Title
Zenith® p-Branch™: Single-Center Study
Brief Summary
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.
Study Type
Interventional
Primary Outcome
Technical Success
Condition
Aortic Aneurysm
Intervention
Endovascular treatment (Zenith® p-Branch™ endovascular graft)
Study Arms / Comparison Groups
Endovascular
Description: Endovascular treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
23
Start Date
June 2012
Completion Date
March 16, 2020
Primary Completion Date
October 2015
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Timothy A. Resch, MD, PhD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT01663064
Organization ID
11-018
Responsible Party
Sponsor
Study Sponsor
Cook Group Incorporated
Study Sponsor
Timothy A. Resch, MD, PhD, Principal Investigator, Skane University Hospital
Verification Date
July 2020