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

October 19, 2012
February 12, 2014
January 2013
August 2019   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01740700 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zenith® p-Branch™ OTS Multicenter Study
Zenith® p-Branch™ Multicenter Study

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).

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm, Abdominal
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
Experimental: p-Branch™
Intervention: Device: p-Branch™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
August 2019
August 2019   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Zach Dawson, PhD 765-463-7537 zdawson@medinst.com
United States
 
NCT01740700
12-002
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Mark A Farber, MD University of North Carolina
Cook
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP