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Zenith® p-Branch® Endovascular Graft Pivotal Study

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: NCT02396199
Recruitment Status : Active, not recruiting
First Posted : March 24, 2015
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Brief Summary:
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm Abdominal Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenith® p-Branch® Pivotal Study
Study Start Date : August 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endovascular
Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Device: Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Other Names:
  • Endovascular graft
  • Endovascular stent
  • Stent-graft
  • Fenestrated graft




Primary Outcome Measures :
  1. Rate of treatment success [ Time Frame: 12 months ]
    Technical success and freedom from type 1 and type 3 endoleaks, aneurysm growth, related SAE's, and related major complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
  • Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
  • Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation

Exclusion Criteria:

  • Age <18 years
  • Life expectancy <2 years
  • Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
  • 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
  • Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
  • 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): NCT02396199


Locations
Show Show 26 study locations
Sponsors and Collaborators
Cook Research Incorporated
Investigators
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Principal Investigator: Mark A Farber, MD University of North Carolina
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Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT02396199    
Other Study ID Numbers: 14-09
First Posted: March 24, 2015    Key Record Dates
Last Update Posted: August 20, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Abdominal aortic aneurysm
Endovascular
Juxtarenal
Pararenal
Fenestrated
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases