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NCT01663064 Clinical Trial

Zenith® p-Branch™: Single-Center Study

Abdominal Aortic Aneurysm Clinical Trial

— PBCT  

Official title:
Zenith® p-Branch™: Single-Center Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01663064
Other study ID # 11-018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2012
Est. completion date March 16, 2020

Study information
Verified date July 2020
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date March 16, 2020
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
Sweden Skane University Hospital Malmo

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Up to 5 years
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