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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type B Aortic Dissection

Intervention / Treatment
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* Device: GORE TAG® Thoracic Endoprosthesis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GORE Conformable TAG® Device Surgical Implant<br> | Device: GORE TAG® Thoracic Endoprosthesis<br>* Endoprosthetic Implant<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| False Lumen Thrombosis | Number of participants with partial or complete False Lumen Thrombosis in the region of the aorta covered by the Conformable TAG device. | Last available follow-up through 5 years | 
| Aortic Rupture | Number of participants with thoracic aortic rupture | Last available follow-up through 5 years | 
| Additional Dissection Based Intervention Rate | 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. | Last available follow-up through 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute, Complicated Type B Dissection