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GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms (TAMBE)

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: NCT02528500
Recruitment Status : Completed
First Posted : August 19, 2015
Results First Posted : July 3, 2018
Last Update Posted : June 28, 2023
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Description
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Brief Summary:
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.

Condition or disease Intervention/treatment Phase
Thoracoabdominal Aortic Aneurysm Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Not Applicable

Detailed Description:
This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
Actual Study Start Date : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : February 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TAMBE Device
Study designed to assess the feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of patients with aortic aneurysms involving the visceral branch vessels. Patients with thoracoabdominal or pararenal abdominal aortic aneurysms are eligible for screening for participation in the study. The particular characteristics of the patient's aneurysm and anatomy will determine ultimate eligibility for enrollment. Only patients who meet all of the eligibility criteria will be enrolled.
 Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
Other Name: TAMBE Device


Outcome Measures
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Primary Outcome Measures :
  1. Absence of the Following Procedural Safety Events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL [ Time Frame: Absence of procedural safety events through 30 days post procedure ]
    Absence of the following procedural safety events through 30 days post-procedure: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL


Secondary Outcome Measures :
  1. Technical Success, Including Individual Components of Technical Success [ Time Frame: 12-month ]
    Components of Technical Success: Successful access to the necessary arterial sites, successful deployment of all required TAMBE Device components, Patency of all required TAMBE Device components and any required accessory components on completion angiography, absence of surgical conversion within 24 hours of initial of procedure

  2. Device Integrity, Including Individual Components of Device Integrity [ Time Frame: 12-month ]
    Components of Device Integrity: Loss of functional patency in any treated branch component due to thrombus or mechanical failure of branch component, loss of functional patency in main body component(s) due to thrombus or mechanical failure of main body components(s) , separation of treated branch component from the main body component(s), separation of the main body component(s) from the accessory components

  3. Patency (Primary, Assisted Primary, and Secondary) [ Time Frame: 12-month ]
    Primary Patency - Blood flow without occlusion maintained through the device without an intervention. Assisted Primary Patency: Blood flow maintained through the device after implant regardless of re-interventions performed. Secondary Patency - Blood flow through the device (following occlusion) regardless of re-interventions performed and freedom from surgical bypass.

  4. Absence of Type I and Type III Endoleaks at One Month Follow-up [ Time Frame: One Month followup ]
    Absence of Type I and Type III endoleaks


Eligibility Criteria
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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:

  1. Aortic aneurysm involving the visceral vessels requiring treatment
  2. Adequate access for TAMBE Device components
  3. Appropriate aortic anatomy to receive the TAMBE Device
  4. Age ≥ 18 years at the time of informed consent signature
  5. Male or infertile female
  6. The patient is considered high risk for open repair as deemed by the treating physician
  7. Capable of complying with protocol requirements, including follow-up
  8. An Informed Consent Form signed by Subject or legal representative Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

  1. Prior aortic surgery
  2. Ruptured or leaking aortic aneurysm
  3. Aneurysmal dilatation due to chronic aortic dissection
  4. Infected aorta
  5. Mycotic aneurysm
  6. Life expectancy <2 years
  7. Myocardial infarction or stroke within 6 weeks of treatment
  8. Systemic infection which may increase risk of endovascular graft infection
  9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
  10. Participation in another drug or medical device study within 1 year of study enrollment
  11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
  12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
  13. Known sensitivities or allergies to the device materials
  14. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
  15. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
  16. Renal Insufficiency Note: Additional Exclusion Criteria may apply
Contacts and Locations
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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): NCT02528500


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
The Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Michel Makaroun, M.D. University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by W.L.Gore & Associates:
Study Protocol  [PDF] December 6, 2017
Statistical Analysis Plan  [PDF] December 11, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT02528500    
Other Study ID Numbers: AAA 13-02
First Posted: August 19, 2015    Key Record Dates
Results First Posted: July 3, 2018
Last Update Posted: June 28, 2023
Last Verified: June 2023
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracoabdominal
Aortic Aneurysm, Thoracic
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Aortic Aneurysm, Abdominal