Zenith® p-Branch™ OTS Multicenter Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01740700
First received: October 19, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention
Aortic Aneurysm, Abdominal
Device: p-Branch™

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zenith® p-Branch™ Multicenter Study

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Technical success [ Time Frame: Within 30 days ] [ Designated as safety issue: Yes ]
    Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.


Estimated Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: p-Branch™ Device: p-Branch™
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.
Other Names:
  • Endovascular graft
  • Endovascular stent
  • Stent-graft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01740700

Contacts
Contact: Zach Dawson, PhD 765-463-7537 zdawson@medinst.com

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Adam Beck, MD    352-273-5484    adam.beck@surgery.ufl.edu   
United States, Indiana
Community Heart and Vascular Hospital Active, not recruiting
Indianapolis, Indiana, United States, 46250
Methodist Hospital of Indiana Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Andres Fajardo, MD    317-274-4966    afajardo@iupui.edu   
United States, Massachusetts
University of Massachusetts Medical School Not yet recruiting
Worster, Massachusetts, United States, 01655
Contact: Andres Schanzer, MD    508-856-5599    Andres.Schanzer@umassmemorial.org   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Gustavo Oderich, MD    507-284-1575    Oderich.gustavo@mayo.edu   
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Luis Sanchez, MD    314-362-7408    sanchezl@wudosis.wustl.edu   
Mercy Hospital Not yet recruiting
St. Louis, Missouri, United States, 63141
Contact: Vito Mantese, MD    314-251-6840    vito.mantese@mercy.net   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Ronald Fairman, MD    215-614-0308    ron.fairman@uphs.upenn.edu   
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Carlos Timaran, MD    214-645-0545    timaran1@msn.com   
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Alan Lumsden, MD    713-441-5200    ablumsden@tmhs.org   
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Mark A Farber, MD University of North Carolina
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01740700     History of Changes
Other Study ID Numbers: 12-002
Study First Received: October 19, 2012
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Abdominal aortic aneurysm
Endovascular
Fenestration
Juxtarenal
Off-the-shelf
Pararenal

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 31, 2014