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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01663064
Recruitment Status : Active, not recruiting
First Posted : August 13, 2012
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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 or disease Intervention/treatment
Aortic Aneurysm Abdominal Aortic Aneurysm Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenith® p-Branch™: Single-Center Study
Study Start Date : June 2012
Primary Completion Date : October 2015
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01663064     History of Changes
Other Study ID Numbers: 11-018
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 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