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

NCT00908388 | Completed Results DMC

• 1 other identifier: TAG 08-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 37

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.

Conditions

Type B Aortic Dissection

Keywords

Acute, Complicated Type B Dissection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• False Lumen Thrombosis

  Last available follow-up through 5 years

• Aortic Rupture

  Last available follow-up through 5 years

• Additional Dissection Based Intervention Rate

  Last available follow-up through 5 years

Study Arms (1)

GORE Conformable TAG® Device Surgical Implant

EXPERIMENTAL

Device: GORE TAG® Thoracic Endoprosthesis

Interventions

GORE TAG® Thoracic Endoprosthesis DEVICE

Endoprosthetic Implant

GORE Conformable TAG® Device Surgical Implant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (37)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

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Los Angeles, California, 90095, United States

Location

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San Francisco, California, 94143, United States

Location

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Stanford, California, 4305, United States

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Torrance, California, 90509, United States

Location

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Gainesville, Florida, 32610, United States

Location

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St. Petersburg, Florida, 33709, United States

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Tampa, Florida, 33606, United States

Location

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60611, United States

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Peoria, Illinois, 61614, United States

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Indianapolis, Indiana, 46202, United States

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Kansas City, Kansas, 66160, United States

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Baltimore, Maryland, 21287, United States

Location

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109, United States

Location

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Grand Rapids, Michigan, 49546, United States

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Minneapolis, Minnesota, 55407, United States

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Minneapolis, Minnesota, 55455, United States

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Plymouth, Minnesota, 55441, United States

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St Louis, Missouri, 63110, United States

Location

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St Louis, Missouri, 63141, United States

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Lebanon, New Hampshire, 03756, United States

Location

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Albany, New York, 12208, United States

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New York, New York, 10032, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28204, United States

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Durham, North Carolina, 27710, United States

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Cleveland, Ohio, 44195, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Memphis, Tennessee, 38120, United States

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Houston, Texas, 77030, United States

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Temple, Texas, 76508, United States

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Charlottesville, Virginia, 22908, United States

Location

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Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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.

  PMID: 30598352 DERIVED

Results Point of Contact

• Title: Abe Letter
• Organization: W.L. Gore & Associates

aletter@wlgore.com

928-864-3113

Study Officials

• Richard Cambria, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: May 25, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 28, 2017
• Last Updated: October 27, 2017
• Results First Posted: May 16, 2014

Record last verified: 2017-09

Locations

US (37)