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Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection

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: NCT00908388
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : May 16, 2014
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
The primary objective of this study is to determine the safety and efficacy of the GORE Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with acute complicated type B aortic dissection.

Condition or disease Intervention/treatment Phase
Type B Aortic Dissection Device: GORE TAG® Thoracic Endoprosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
Study Start Date : October 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GORE Conformable TAG® Device Surgical Implant Device: GORE TAG® Thoracic Endoprosthesis
Endoprosthetic Implant

Primary Outcome Measures :
  1. All-cause Mortality Incidence Through 30 Days Post-treatment [ Time Frame: 30 Days Post-Treatment ]
  2. Exclusion of Primary Entry Tear [ Time Frame: 1 month ]
    Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery

Secondary Outcome Measures :
  1. False Lumen Thrombosis [ Time Frame: Last available follow-up through 5 years ]
    Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device.

  2. Aortic Rupture [ Time Frame: Last available follow-up through 5 years ]
    Number of participants with thoracic aortic rupture

  3. Additional Dissection Based Intervention Rate [ Time Frame: Last available follow-up through 5 years ]
    Number of participants that required additional dissection-based interventions defined as interventions related to malperfusion, rupture, or both, as adjudicated by CEC or Sponsor. Additional dissection based interventions included: peripheral stenting, fenestration, implantation of additional endovascular stent-grafts or other surgeries.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Presence of acute complicated type B aortic dissection:

    • Dissection is acute Time from symptom onset to dissection diagnosis ≤14 days
    • Dissection is complicated

    Subject must present with at least one of the following:

    • Rupture in the setting of an aortic dissection defined as hemorrhage outside of the aortic boundaries -which is noted by CT scan (hemorrhage must be differentiated from reactive effusions by the investigator, or if equivocal, having elevated Hounsefield units as determined by the radiologist).
    • Clinical evidence of malperfusion, in the setting of an aortic dissection, defined as:

      • Clinical or radiographic evidence of visceral hypoperfusion.
      • Clinical or radiographic evidence of renal hypoperfusion.
      • Clinical or radiographic evidence of lower extremity hypoperfusion.
      • Clinical or radiographic evidence of spinal cord hypoperfusion.

        • Dissection is type B Entire dissection is distal to the left subclavian artery
        • Primary Treatment Indication is Class 1 Aortic Dissection 46 Classical aortic dissection with intimal flap between true and false lumen with double barrel flow in thoracic aorta
        • Subjects with multiple entry tears are allowed to be enrolled in the study
  2. Age 18 to 80 years
  3. Primary treatment is endovascular treatment with the CTAG device. Adjunctive treatments may include left subclavian artery revascularization, percutaneous fenestration, aortic stenting, peripheral vessel stenting, surgical fenestration, and/or peripheral artery bypass
  4. Proximal landing zone characteristics include:

    • Proximal extent of intended proximal landing zone cannot be dissected
    • Length ≥ 2.0 cm proximal to the primary entry tear
    • Trans-aortic diameter at proximal extent of intended landing zone between 16-42 mm (diameter assessed by flow lumen and thrombus, if present; calcium excluded)
    • Cannot be aneurysmal, heavily calcified, or have excessive intraluminal thrombus
    • Must be native aorta
    • May include left subclavian artery, if necessary
  5. Subject is capable of complying with protocol requirements, including follow-up
  6. Informed Consent Form is signed by subject or legal representative

Exclusion Criteria:

  1. Primary treatment indication is Class 2-5 aortic dissection (intramural hematoma, limited dissection, penetrating atherosclerotic ulcer, iatrogenic dissection, traumatic dissection) 46
  2. Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair (dissection extension into the abdominal aorta is acceptable)
  3. Prior repair of DTA
  4. Infected aorta
  5. Subject has a systemic infection and may be at increased risk of endovascular graft infection
  6. Persistent refractory shock (systolic blood pressure <90 mm Hg)
  7. Bowel necrosis (Bowel necrosis will be characterized by direct observation with surgical exploration, or elevated serum lactate level and CT findings of portal venous gas, free intra-abdominal gas, pneumatosis intramural gas, and poor mucosal enhancement of thickened bowel wall)
  8. Renal failure , defined as baseline creatinine ≥ 2.5 mg/dl
  9. ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation)
  10. Pregnant female
  11. Major surgery within 30 days of treatment (other than left subclavian artery bypass or transposition)
  12. Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  13. Treatment in another drug or medical device study within 1 year of study enrollment
  14. History of stimulant abuse, e.g., cocaine or amphetamine, within 1 year of treatment
  15. Tortuous or stenotic iliac and/or femoral arteries and the inability to use a conduit for vascular access
  16. Planned coverage of left carotid or celiac arteries with the CTAG device
  17. The planned endovascular procedure involves alterations to the CTAG device
  18. Subject has known sensitivities or allergies to the device materials

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): NCT00908388

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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, California
Los Angeles, California, United States, 90095
San Francisco, California, United States, 94143
Stanford, California, United States, 4305
Torrance, California, United States, 90509
United States, Florida
Gainesville, Florida, United States, 32610
Saint Petersburg, Florida, United States, 33709
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611
Peoria, Illinois, United States, 61614
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02215
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Minneapolis, Minnesota, United States, 55407
Minneapolis, Minnesota, United States, 55455
Plymouth, Minnesota, United States, 55441
United States, Missouri
Saint Louis, Missouri, United States, 63110
Saint Louis, Missouri, United States, 63141
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, New York
Albany, New York, United States, 12208
New York, New York, United States, 10032
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
Charlotte, North Carolina, United States, 28204
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Memphis, Tennessee, United States, 38120
United States, Texas
Houston, Texas, United States, 77030
Temple, Texas, United States, 76508
United States, Virginia
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
W.L.Gore & Associates
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Principal Investigator: Richard Cambria, MD Massachusetts General Hospital
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: NCT00908388    
Other Study ID Numbers: TAG 08-01
First Posted: May 25, 2009    Key Record Dates
Results First Posted: May 16, 2014
Last Update Posted: October 27, 2017
Last Verified: September 2017
Keywords provided by W.L.Gore & Associates:
Acute, Complicated Type B Dissection
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Vascular Diseases
Cardiovascular Diseases