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

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention
Aortic Aneurysm
Abdominal Aortic Aneurysm
Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)

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

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular
Endovascular treatment
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.

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663064

Contacts
Contact: Trine Toelboell, DVM, PhD +45 56868971 Trine.Toelboell@CookMedical.com

Locations
Sweden
Skane University Hospital Recruiting
Malmo, Sweden, SE-205 02
Contact: Timothy A. Resch, MD, PhD    +46 40331000    timothyresch@gmail.com   
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Timothy A. Resch, MD, PhD Skane University Hospital
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01663064     History of Changes
Other Study ID Numbers: 11-018
Study First Received: August 2, 2012
Last Updated: February 3, 2014
Health Authority: Sweden: Medical Products Agency

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 April 17, 2014