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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated
ClinicalTrials.gov Identifier:
NCT01663064
First received: August 2, 2012
Last updated: June 30, 2017
Last verified: June 2017
  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: None (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 Group Incorporated:

Primary Outcome Measures:
  • Technical Success [ Time Frame: Up to 5 years ]
    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.


Enrollment: 23
Study Start Date: June 2012
Estimated Study Completion Date: July 2020
Primary Completion Date: October 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Sweden
Skane University Hospital
Malmo, Sweden, SE-205 02
Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Timothy A. Resch, MD, PhD Skane University Hospital
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01663064     History of Changes
Other Study ID Numbers: 11-018
Study First Received: August 2, 2012
Last Updated: June 30, 2017

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 23, 2017