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

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.

Study Overview

• Status: Completed
• Conditions: Type B Aortic Dissection
• Intervention / Treatment: Device: GORE TAG® Thoracic Endoprosthesis

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
  • California
    • Los Angeles, California, United States, 90095
    • San Francisco, California, United States, 94143
    • Stanford, California, United States, 4305
    • Torrance, California, United States, 90509
  • Florida
    • Gainesville, Florida, United States, 32610
    • Saint Petersburg, Florida, United States, 33709
    • Tampa, Florida, United States, 33606
  • Georgia
    • Atlanta, Georgia, United States, 30322
  • Illinois
    • Chicago, Illinois, United States, 60611
    • Peoria, Illinois, United States, 61614
  • Indiana
    • Indianapolis, Indiana, United States, 46202
  • Kansas
    • Kansas City, Kansas, United States, 66160
  • Maryland
    • Baltimore, Maryland, United States, 21287
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
    • Boston, Massachusetts, United States, 02114
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
    • Grand Rapids, Michigan, United States, 49546
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
    • Minneapolis, Minnesota, United States, 55407
    • Plymouth, Minnesota, United States, 55441
  • Missouri
    • Saint Louis, Missouri, United States, 63110
    • Saint Louis, Missouri, United States, 63141
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
  • New York
    • Albany, New York, United States, 12208
    • New York, New York, United States, 10032
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
    • Charlotte, North Carolina, United States, 28204
    • Durham, North Carolina, United States, 27710
  • Ohio
    • Cleveland, Ohio, United States, 44195
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
    • Pittsburgh, Pennsylvania, United States, 15213
  • Tennessee
    • Memphis, Tennessee, United States, 38120
  • Texas
    • Houston, Texas, United States, 77030
    • Temple, Texas, United States, 76508
  • Virginia
    • Charlottesville, Virginia, United States, 22908
  • Wisconsin
    • Madison, Wisconsin, United States, 53792

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GORE Conformable TAG® Device Surgical Implant	Device: GORE TAG® Thoracic Endoprosthesis; Endoprosthetic Implant

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Richard Cambria, MD, Massachusetts General Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: April 3, 2009
• First Submitted That Met QC Criteria: May 22, 2009
• First Posted (Estimate): May 25, 2009

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Acute, Complicated Type B Dissection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: TAG 08-01