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

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:
NCT01663064
First received: August 2, 2012
Last updated: February 3, 2014
Last verified: February 2014

August 2, 2012
February 3, 2014
June 2012
June 2014   (final data collection date for primary outcome measure)
Technical Success [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.
Same as current
Complete list of historical versions of study NCT01663064 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zenith® p-Branch™: Single-Center Study
Zenith® p-Branch™: Single-Center Study

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Aneurysm
  • Abdominal Aortic Aneurysm
Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)
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.
Experimental: Endovascular
Endovascular treatment
Intervention: Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
March 2017
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Trine Toelboell, DVM, PhD +45 56868971 Trine.Toelboell@CookMedical.com
Sweden
 
NCT01663064
11-018
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Timothy A. Resch, MD, PhD Skane University Hospital
Cook
February 2014

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