Zenith® p-Branch™: Single-Center Study (PBCT)
Primary Purpose
Aortic Aneurysm, Abdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Endovascular treatment (Zenith® p-Branch™ endovascular graft)
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm focused on measuring Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
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
Sites / Locations
- Skane University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endovascular
Arm Description
Endovascular treatment
Outcomes
Primary Outcome Measures
Technical Success
Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01663064
Brief Title
Zenith® p-Branch™: Single-Center Study
Acronym
PBCT
Official Title
Zenith® p-Branch™: Single-Center Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
March 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal Aortic Aneurysm
Keywords
Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endovascular
Arm Type
Experimental
Arm Description
Endovascular treatment
Intervention Type
Device
Intervention Name(s)
Endovascular treatment (Zenith® p-Branch™ endovascular graft)
Intervention Description
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 Outcome Measure Information:
Title
Technical Success
Description
Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy A. Resch, MD, PhD
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skane University Hospital
City
Malmo
ZIP/Postal Code
SE-205 02
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Zenith® p-Branch™: Single-Center Study
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