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Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

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ClinicalTrials.gov Identifier: NCT01524211
Recruitment Status : Recruiting
First Posted : February 1, 2012
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
William Cook Australia
Information provided by (Responsible Party):
Lee, W. Anthony, M.D. FACS

Brief Summary:
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 or disease Intervention/treatment Phase
Thoracoabdominal Aortic Aneurysm Device: Zenith® t-Branch Phase 2

Detailed Description:
Study Update as of 10/31/2017;84 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms
Study Start Date : January 2012
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Treatment Arm
All subjects enrolled will receive endovascular treatment with the investigational Zenith t-Branch Endovascular Graft.
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.



Primary Outcome Measures :
  1. Early Mortality [ Time Frame: 30 days post implant of the branch endografts ]
    The primary aim of this study is to determine the rate of early mortality after branch endograft treatment.


Secondary Outcome Measures :
  1. Rates of Neurologic Complications/Late Branch Vessel Patency [ Time Frame: Day 0-Day 30 (Early) Day 31-1825 (Late) ]
    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



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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

The patient must have one of the following:

  1. Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or
  2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or
  3. Penetrating ulcers: ≥20mm in depth or
  4. Chronic type B aortic dissections: ≥50mm total aortic diameter or
  5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.

Additional criteria for LP material

• Iliofemoral access vessels <8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator

Exclusion Criteria

General 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 by subject and/or Legally Authorized Representative (LAR); should one be utilized

Medical Criteria

  1. Uncontrolled systemic infection
  2. Untreatable malignancy
  3. Uncontrollable anaphylaxis to iodinated contrast
  4. Known allergy(ies) to device materials

Anatomic Criteria

  1. Any pathology of mycotic origin
  2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
  3. Inability to insert the Zenith® t-Branch device through iliofemoral approach
  4. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
  5. Proximal landing zone length <25mm to allow secure fixation and seal
  6. Proximal landing zone diameter of <24mm or >42mm
  7. Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries
  8. Distal landing zone diameter of <14mm or >30mm in the abdominal aorta, or <7mm or >28mm in the iliac arteries

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): 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

Responsible Party: Lee, W. Anthony, M.D. FACS
ClinicalTrials.gov Identifier: NCT01524211     History of Changes
Other Study ID Numbers: IDE G110081
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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