Trial record 1 of 1 for:    NCT00908388
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Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00908388
First received: April 3, 2009
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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 Intervention
Type B Aortic Dissection
Device: GORE TAG® Thoracic Endoprosthesis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection

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

Primary Outcome Measures:
  • All-cause Mortality Incidence Through 30 Days Post-treatment [ Time Frame: 30 Days Post-Treatment ] [ Designated as safety issue: Yes ]
  • Exclusion of Primary Entry Tear [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Number of subjects with successful coverage of Primary Entry Tear as assessed by the Core Lab using contrast-enhanced CT imagery


Secondary Outcome Measures:
  • False Lumen Thrombosis [ Time Frame: Last available follow-up through 2 years ] [ Designated as safety issue: No ]
    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 2 years ] [ Designated as safety issue: No ]
  • Additional Dissection Based Intervention Rate [ Time Frame: Last available follow-up through 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: October 2009
Estimated Study Completion Date: June 2017
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GORE Conformable TAG® Device Surgical Implant Device: GORE TAG® Thoracic Endoprosthesis
Endoprosthetic Implant

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908388

  Show 37 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Richard Cambria, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00908388     History of Changes
Other Study ID Numbers: TAG 08-01
Study First Received: April 3, 2009
Results First Received: October 24, 2013
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by W.L.Gore & Associates:
Acute, Complicated Type B Dissection

ClinicalTrials.gov processed this record on October 29, 2014