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Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02264977
First Posted: October 15, 2014
Last Update Posted: September 27, 2017
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.
Information provided by (Responsible Party):
W.L.Gore & Associates
  Purpose
The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the aortic arch

Condition Intervention
Aneurysm of Aortic Arch Device: Branched TAG® Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (Branched TAG® Device) in the Treatment of Aortic Arch Aneurysms

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Number of Participants With Successful Study Device Access [ Time Frame: During treatment procedure (day 0) ]
    Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.

  • Number of Participants With Successful Study Device Deployment [ Time Frame: During treatment procedure (day 0) ]
    Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.

  • Number of Participants With Primary Procedural Side Branch Patency [ Time Frame: At conclusion of the treatment procedure (day 0) ]
    The presence of forward flow through the implanted Side Branch Component into the target branch vessel.


Secondary Outcome Measures:
  • Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab [ Time Frame: 1 month post procedure ]
  • Number of Participants With 1 Month Device Related Endoleaks Assessed by an Independent Core Lab [ Time Frame: 1 month post procedure ]
    Device-related endoleaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the landing zone (endoleak type IA or IB) OR the junction between the Aortic Component and either the Side Branch Component or the Aortic Extender (type III endoleak).


Enrollment: 9
Actual Study Start Date: April 2015
Estimated Study Completion Date: July 2021
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Branched TAG® Device
Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis
Device: Branched TAG® Device

  Eligibility

Information from the National Library of Medicine

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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:

  1. Presence of aortic aneurysm involving the aortic arch deemed to warrant surgical repair which requires proximal graft placement in Zone 0 or Zone 1:

    1. Fusiform (≥ 55 mm), or
    2. Fusiform (>2 times native aortic diameter), or
    3. Saccular (no diameter criteria)
  2. Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator
  3. Age ≥18 years at time of informed consent signature
  4. Subject is capable of complying with protocol requirements, including follow-up
  5. Informed Consent Form (ICF) is signed by Subject or legal representative
  6. Must have appropriate proximal aortic landing zone, defined as:

    1. Must require placement of the proximal extent of the Aortic Component in Zone 0 or Zone 1 for exclusion of the lesion
    2. Acceptable proximal landing zone outer curvature length for the required device
    3. Landing zone inner diameters between 16-48 mm in Zone 1 Subjects and 24-48mm in Zone 0 Subjects
    4. Landing zone, which must include either the brachiocephalic or left common carotid native ostium, cannot be aneurysmal, heavily calcified, or heavily thrombosed
  7. Must have appropriate distal aortic landing zone, defined as:

    1. Outer curvature length must be ≥2cm proximal to the celiac artery
    2. Aortic inner diameters between 16-48 mm (diameter must be between 16-42mm if using distal TAG® Device extension)
    3. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
    4. Landing zone in native aorta or previously implanted GORE® TAG® Device
  8. Must have appropriate target branch vessel landing zone, defined as:

    1. Length of ≥3 cm proximal to first major branch vessel if using Aortic Component with 8 mm portal diameter, or length of ≥2.5 cm proximal to first major branch vessel if using Aortic Component with 12 mm portal diameter (required for Zone 0 Subjects)
    2. Target branch vessel inner diameters of 6-15 mm if using Aortic Component with 8mm portal diameter, or inner diameters of 11-18 mm if using Aortic Component with 12mm portal diameter (required for Zone 0 Subjects)
    3. Target branch vessel landing zone must be in native aorta that cannot be aneurysmal, heavily calcified, or heavily thrombosed

Exclusion Criteria:

  1. Concomitant aneurysm/disease of the ascending aorta, or abdominal aorta requiring repair
  2. Previous endovascular repair of the ascending aorta
  3. Previous endovascular repair of the DTA with a non-Gore device
  4. Surgery within 30 days of treatment
  5. Infected aorta
  6. Dissection of the aorta
  7. Intramural hematoma of the aortic arch or DTA without aneurysm
  8. Life expectancy <2 years
  9. Myocardial infarction or stroke within 6 weeks prior to treatment
  10. Patient has a systemic infection and may be at increased risk of endovascular graft infection
  11. Pregnant female at time of informed consent signature
  12. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
  13. Participation in another drug or medical device study within one year of study enrollment
  14. Known history of drug abuse within one year of treatment
  15. Significant thrombus or atheroma in the aortic arch
  16. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
  17. Planned coverage of celiac artery
  18. Patient has known sensitivities or allergies to the device materials
  19. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
  20. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
  21. Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
  22. Mycotic aneurysm
  23. Persistent refractory shock (systolic blood pressure <90 mm Hg)
  24. Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
  Contacts and Locations
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): NCT02264977


Locations
United States, California
Leland Stanford Junior University
Stanford, California, United States, 94305-5407
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New Hampshire
The Hitchcock Foundation (Dartmouth Hitchcock Medical Center)
Lebanon, New Hampshire, United States, 03756
United States, Pennsylvania
Hospital at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Univerisity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Michael D Dake, MD Stanford University
  More Information

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT02264977     History of Changes
Other Study ID Numbers: SSB 11-03
First Submitted: October 8, 2014
First Posted: October 15, 2014
Results First Submitted: July 7, 2017
Results First Posted: August 2, 2017
Last Update Posted: September 27, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases