Overview

This trial is active, not recruiting.

Condition type b aortic dissection
Treatment gore tag® thoracic endoprosthesis
Sponsor W.L.Gore & Associates
Start date October 2009
End date February 2012
Trial size 50 participants
Trial identifier NCT00908388, TAG 08-01

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
gore tag® thoracic endoprosthesis
Endoprosthetic Implant

Primary Outcomes

Measure
All-cause Mortality Incidence Through 30 Days Post-treatment
time frame: 30 Days Post-Treatment
Exclusion of Primary Entry Tear
time frame: 1 month

Secondary Outcomes

Measure
False Lumen Thrombosis
time frame: Last available follow-up through 2 years
Aortic Rupture
time frame: Last available follow-up through 2 years
Additional Dissection Based Intervention Rate
time frame: Last available follow-up through 2 years

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria

  • 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
  • Age 18 to 80 years
  • 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
  • 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
  • Subject is capable of complying with protocol requirements, including follow-up
  • Informed Consent Form is signed by subject or legal representative

Exclusion Criteria

  • Primary treatment indication is Class 2-5 aortic dissection (intramural hematoma, limited dissection, penetrating atherosclerotic ulcer, iatrogenic dissection, traumatic dissection) 46
  • Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta requiring repair (dissection extension into the abdominal aorta is acceptable)
  • Prior repair of DTA
  • Infected aorta
  • Subject has a systemic infection and may be at increased risk of endovascular graft infection
  • Persistent refractory shock (systolic blood pressure <90 mm Hg)
  • 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)
  • Renal failure , defined as baseline creatinine ≥ 2.5 mg/dl
  • ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation)
  • Pregnant female
  • Major surgery within 30 days of treatment (other than left subclavian artery bypass or transposition)
  • Degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  • Treatment in another drug or medical device study within 1 year of study enrollment
  • History of stimulant abuse, e.g., cocaine or amphetamine, within 1 year of treatment
  • Tortuous or stenotic iliac and/or femoral arteries and the inability to use a conduit for vascular access
  • Planned coverage of left carotid or celiac arteries with the CTAG device
  • The planned endovascular procedure involves alterations to the CTAG device
  • Subject has known sensitivities or allergies to the device materials

Additional Information

Official title Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
Principal investigator Richard Cambria, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.