Zenith® p-Branch™: Single-Center Study (PBCT)

Cook Group

Status: Completed

Conditions: Abdominal Aortic Aneurysm; Aortic Aneurysm

Treatments: Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01663064

11-018 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Endovascular

Experimental group

Description:

Endovascular treatment

Treatment:

Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)