Zenith® p-Branch™: Single-Center Study

Not Applicable

Completed

• Conditions: Aortic Aneurysm; Abdominal Aortic Aneurysm
• Interventions: Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)

• Registration Number: NCT01663064
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-13
• Primary Completion: 2015-10
• Study Completion: 2020-03-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endovascular	Endovascular treatment (Zenith® p-Branch™ endovascular graft)	Endovascular treatment

Primary Outcome Measures

Name	Time	Method
Technical Success	Up to 5 years	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.

Trial Locations

Locations (1)

Skane University Hospital; 🇸🇪 Malmo, Sweden