Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Lee, W. Anthony, M.D. FACS
Sponsor:
Collaborator:
William Cook Australia
Information provided by (Responsible Party):
Lee, W. Anthony, M.D. FACS
ClinicalTrials.gov Identifier:
NCT01524211
First received: January 30, 2012
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system for the treatment of aortic aneurysms.


Condition Intervention Phase
Thoracoabdominal Aortic Aneurysm
Device: Zenith® t-Branch
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by Lee, W. Anthony, M.D. FACS:

Primary Outcome Measures:
  • Early Mortality [ Time Frame: 30 days post implant of the branch endografts ] [ Designated as safety issue: No ]
    The primary aim of this study is to determine the rate of early mortality after branch endograft treatment.


Secondary Outcome Measures:
  • Rates of Neurologic Complications/Late Branch Vessel Patency [ Time Frame: Day 0-Day 30 (Early) Day 31-1825 (Late) ] [ Designated as safety issue: No ]
    The secondary aims of this study are to determine the rates of neurologic complications and late branch vessel patency after branch endograft treatment, and the fractional/proportional/percent applicability/eligibility of the (standard, off-the-shelf) Zenith® t-Branch in all patients who present with thoracoabdominal aortic aneurysms


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Zenith® t-Branch
    The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.
Detailed Description:

Study Update as of 7/25/2013 25 Subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject must have one of the following:

  1. Degenerative, atherosclerotic thoracoabdominal aortic aneurysm (fusiform or saccular): ≥55mm in diameter or
  2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year.
  3. Penetrating ulcers: ≥20mm in depth or
  4. Chronic type B aortic dissections: ≥55mm total aortic diameter or
  5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size

Exclusion Criteria:

  1. Life-expectancy less than 12 months
  2. Refusal to receive blood products
  3. Age <18 years
  4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  5. Unwilling to comply with the follow-up schedule
  6. Inability or refusal to give informed consent

Medical Exclusion Criteria

  1. Uncontrolled systemic infection
  2. Untreatable malignancy
  3. Heart Attack(MI) or stroke in last 90 days
  4. Unstable/Ruptured aneurysm
  5. Uncontrollable anaphylaxis to iodinated contrast
  6. Known allergy(ies) to device materials
  7. History of chronic abdominal pain
  8. Coagulopathy or any bleeding disorder
  9. Contraindication to general anesthesia

Anatomic Exclusion Criteria

  1. Any pathology of mycotic origin
  2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
  3. Extensive thrombus or calcifications in the aortic arch
  4. Excessive tortuosity precluding safe passage of the Zenith® t-Branch or its components
  5. Inability to insert the Zenith® t-Branch device through iliofemoral approach
  6. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
  7. Proximal landing zone length <25mm to allow secure fixation and seal
  8. Proximal landing zone diameter of <24mm or >38mm
  9. Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries
  10. Distal landing zone diameter of <24mm or >30mm in the abdominal aorta, or <7mm or >20mm in the iliac arteries
  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: NCT01524211

Contacts
Contact: Lisamarie Kernicky, RN;BSN;CCRC 561-955-5239 lkernicky@brrh.com

Locations
United States, Florida
Boca Raton Regional Hospital (BRRH) Recruiting
Boca Raton, Florida, United States, 33486
Contact: Lisamarie Kernicky, RN;BSN;CCRC    561-955-5239    lkernicky@brrh.com   
Sponsors and Collaborators
Lee, W. Anthony, M.D. FACS
William Cook Australia
Investigators
Principal Investigator: W. Anthony Lee, MD Lynn Heart and Vascular Institute, Boca Raton Regional Hospital
  More Information

No publications provided

Responsible Party: Lee, W. Anthony, M.D. FACS
ClinicalTrials.gov Identifier: NCT01524211     History of Changes
Other Study ID Numbers: IDE G110081
Study First Received: January 30, 2012
Last Updated: July 31, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Lee, W. Anthony, M.D. FACS:
Aortic Aneurysms

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014