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

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

Tracking Information

• First Submitted Date: April 3, 2009
• First Posted Date: May 25, 2009
• Results First Submitted Date: October 24, 2013
• Results First Posted Date: May 16, 2014
• Last Update Posted Date: October 27, 2017
• Study Start Date: October 2009
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type B Aortic Dissection

Intervention

Device: GORE TAG® Thoracic Endoprosthesis

Endoprosthetic Implant

Study Arms

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 8, 2012): 50
• Original Enrollment: Not Provided
• Actual Study Completion Date: February 28, 2017
• Actual Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00908388
• Other Study ID Numbers: TAG 08-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: W.L.Gore & Associates
• Original Responsible Party: [Redacted]
• Current Study Sponsor: W.L.Gore & Associates
• Original Study Sponsor: [Redacted]
• Collaborators: Not Provided

Investigators

• Principal Investigator: Richard Cambria, MD; Massachusetts General Hospital

• PRS Account: W.L.Gore & Associates
• Verification Date: September 2017