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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
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Tracking Information
First Submitted Date  ICMJE April 3, 2009
First Posted Date  ICMJE May 25, 2009
Results First Submitted Date  ICMJE October 24, 2013
Results First Posted Date  ICMJE May 16, 2014
Last Update Posted Date October 27, 2017
Study Start Date  ICMJE October 2009
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
  • All-cause Mortality Incidence Through 30 Days Post-treatment [ Time Frame: 30 Days Post-Treatment ]
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
  • 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.
  • Aortic Rupture [ Time Frame: Last available follow-up through 5 years ]
    Number of participants with thoracic aortic rupture
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
Official Title  ICMJE Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type B Aortic Dissection
Intervention  ICMJE Device: GORE TAG® Thoracic Endoprosthesis
Endoprosthetic Implant
Study Arms  ICMJE Experimental: GORE Conformable TAG® Device Surgical Implant
Intervention: Device: GORE TAG® Thoracic Endoprosthesis
Publications * Panthofer AM, Olson SL, Harris DG, Matsumura JS. Derivation and validation of thoracic sarcopenia assessment in patients undergoing thoracic endovascular aortic repair. J Vasc Surg. 2019 May;69(5):1379-1386. doi: 10.1016/j.jvs.2018.08.180. Epub 2018 Dec 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2012)
50
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00908388
Other Study ID Numbers  ICMJE TAG 08-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party W.L.Gore & Associates
Study Sponsor  ICMJE W.L.Gore & Associates
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard Cambria, MD Massachusetts General Hospital
PRS Account W.L.Gore & Associates
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP