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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type B Aortic Dissection	Device: GORE TAG® Thoracic Endoprosthesis	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
• Study Start Date: October 2009
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 28, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. All-cause Mortality Incidence Through 30 Days Post-treatment [ Time Frame: 30 Days Post-Treatment ]
2. 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

Secondary Outcome Measures :

1. 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.
2. Aortic Rupture [ Time Frame: Last available follow-up through 5 years ]
   Number of participants with thoracic aortic rupture
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Alabama

Birmingham, Alabama, United States, 35294

United States, California

Los Angeles, California, United States, 90095

San Francisco, California, United States, 94143

Stanford, California, United States, 4305

Torrance, California, United States, 90509

United States, Florida

Gainesville, Florida, United States, 32610

Saint Petersburg, Florida, United States, 33709

Tampa, Florida, United States, 33606

United States, Georgia

Atlanta, Georgia, United States, 30322

United States, Illinois

Chicago, Illinois, United States, 60611

Peoria, Illinois, United States, 61614

United States, Indiana

Indianapolis, Indiana, United States, 46202

United States, Kansas

Kansas City, Kansas, United States, 66160

United States, Maryland

Baltimore, Maryland, United States, 21287

United States, Massachusetts

Boston, Massachusetts, United States, 02114

Boston, Massachusetts, United States, 02215

United States, Michigan

Ann Arbor, Michigan, United States, 48109

Grand Rapids, Michigan, United States, 49546

United States, Minnesota

Minneapolis, Minnesota, United States, 55407

Minneapolis, Minnesota, United States, 55455

Plymouth, Minnesota, United States, 55441

United States, Missouri

Saint Louis, Missouri, United States, 63110

Saint Louis, Missouri, United States, 63141

United States, New Hampshire

Lebanon, New Hampshire, United States, 03756

United States, New York

Albany, New York, United States, 12208

New York, New York, United States, 10032

United States, North Carolina

Chapel Hill, North Carolina, United States, 27599

Charlotte, North Carolina, United States, 28204

Durham, North Carolina, United States, 27710

United States, Ohio

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Pittsburgh, Pennsylvania, United States, 15213

United States, Tennessee

Memphis, Tennessee, United States, 38120

United States, Texas

Houston, Texas, United States, 77030

Temple, Texas, United States, 76508

United States, Virginia

Charlottesville, Virginia, United States, 22908

United States, Wisconsin

Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

W.L.Gore & Associates

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT00908388
• Other Study ID Numbers: TAG 08-01
• First Posted: May 25, 2009
• Results First Posted: May 16, 2014
• Last Update Posted: October 27, 2017
• Last Verified: September 2017

Keywords provided by W.L.Gore & Associates:

Acute, Complicated Type B Dissection

Additional relevant MeSH terms:

Aneurysm, Dissecting; Aneurysm; Vascular Diseases; Cardiovascular Diseases