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Zenith® p-Branch® OTS Multicenter Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated
ClinicalTrials.gov Identifier:
NCT01740700
First received: October 19, 2012
Last updated: February 15, 2017
Last verified: February 2017
  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: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Zenith® p-Branch® Multicenter Study

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated:

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


Enrollment: 30
Study Start Date: January 2013
Estimated Study Completion Date: August 2020
Primary Completion Date: June 2015 (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 abdomen, 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Indiana
Methodist Hospital of Indiana
Indianapolis, Indiana, United States, 46202
Community Heart and Vascular Hospital
Indianapolis, Indiana, United States, 46250
United States, Massachusetts
University of Massachusetts Medical School
Worster, Massachusetts, United States, 01655
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
Mercy Hospital
St. Louis, Missouri, United States, 63141
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
The Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Mark A Farber, MD University of North Carolina
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01740700     History of Changes
Other Study ID Numbers: 12-002
Study First Received: October 19, 2012
Last Updated: February 15, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Cook Group Incorporated:
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 August 18, 2017