Have you or your loved ones been diagnosed with aortic aneurysm abdominal?

You may be eligible to participate in a aortic aneurysm abdominal clinical trial.

Have you or your loved ones been diagnosed with aortic aneurysm abdominal? You may be eligible to participate in a aortic aneurysm abdominal clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Recruiting for this study? Get access to patient recruitment tools.
Aortic Aneurysm Abdominal Clinical Trial
NCT02396199 | Interventional

Have you or your loved ones been diagnosed with aortic aneurysm abdominal?

You may be eligible to participate in a aortic aneurysm abdominal clinical trial.

Have you or your loved ones been diagnosed with aortic aneurysm abdominal? You may be eligible to participate in a aortic aneurysm abdominal clinical trial.

Recruiting

Male & Female

18 Years +

This study is looking to recruit 82 Participants

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.

Available locations
Emory University Hospital

Emory University Hospital

Recruiting 1364 Clifton Road Northeast, Atlanta, GA, USA 30322

Johns Hopkins Hospital

Johns Hopkins Hospital

Recruiting 1800 Orleans Street, Baltimore, MD, USA 21287

University of Alabama Birmingham Hosptial

University of Alabama Birmingham Hosptial

Recruiting Birmingham, AL, USA 35233

Boca Raton Community Hospita

Boca Raton Community Hospita

Recruiting 800 Meadows Road, Boca Raton, FL, USA 33486

UT Southwestern

UT Southwestern

Recruiting 5323 Harry Hines Boulevard, Dallas, TX, USA 75235

Hartford Hospital

Hartford Hospital

Recruiting Hartford, CT, USA 06102-8000

Michael E DeBakey VA Medical Center

Michael E DeBakey VA Medical Center

Recruiting 2002 Holcombe Boulevard, Houston, TX, USA 77030

The Methodist Hospital Smith Tower

The Methodist Hospital Smith Tower

Recruiting 6560 Fannin Street, Houston, TX, USA 77030

Methodist Hospital of Indiana

Methodist Hospital of Indiana

Recruiting 1701 North Senate Avenue, Indianapolis, IN, USA 46202


Details for the study
Brief Title

Zenith® p-Branch® Endovascular Graft Pivotal Study

Official Title

Zenith® p-Branch® Pivotal Study

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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Rate of treatment success

Technical success and freedom from type 1 and type 3 endoleaks, aneurysm growth, related SAE's, and related major complications

Study 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
      
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