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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01663064
First received: August 2, 2012
Last updated: November 5, 2014
Last verified: November 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: 30
Study Start Date: June 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 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
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: 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: November 5, 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
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014