Zenith® p-Branch® OTS Multicenter Study

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

Zenith® p-Branch® Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740700
• Other study ID #: 12-002
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 22, 2020

Study information

• Verified date: December 2020
• Source: Cook Group Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 22, 2020
• Est. primary completion date: June 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 or 2 times the normal aortic diameter
• Pararenal or juxtarenal AAA with history of growth =0.5 cm/year
• Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation

Exclusion Criteria:

• Age <18 years
• Life expectancy <2 years
• Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
• 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
• Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
• Additional medical restrictions as specified in the Clinical Investigation Plan
• Additional anatomical restrictions as specified in the Clinical Investigation Plan

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• p-Branch®
Instead of making a large incision in the abdomen, 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
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	The Methodist Hospital	Houston	Texas
United States	Community Heart and Vascular Hospital	Indianapolis	Indiana
United States	Methodist Hospital of Indiana	Indianapolis	Indiana
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Mercy Hospital	Saint Louis	Missouri
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cook Research Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.	Within 30 days