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Type B Aortic DissectionNCT00908388

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

A study testing GORE TAG® Thoracic Endoprosthesis in people with Type B Aortic Dissection, run by W.L.Gore & Associates at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type B Aortic Dissection
What is being tested?
GORE TAG® Thoracic Endoprosthesis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
37 sitesUnited States
Study dates
Oct 2009to 28 Feb 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • Study site

    Albany, New York, 12208

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Charlottesville, Virginia, 22908

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Kansas City, Kansas, 66160

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Los Angeles, California, 90095

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Minneapolis, Minnesota, 55407

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    New York, New York, 10032

  • Study site

    Peoria, Illinois, 61614

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Plymouth, Minnesota, 55441

  • Study site

    San Francisco, California, 94143

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63141

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Stanford, California, 4305

  • Study site

    Tampa, Florida, 33606

  • Study site

    Temple, Texas, 76508

  • Study site

    Torrance, California, 90509

Other trials in United States

About this study

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.

Being tested
GORE TAG® Thoracic Endoprosthesis
Keywords
Acute, Complicated Type B Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE TAG® Thoracic EndoprosthesisDevice

    Endoprosthetic Implant

Study groups in NCT00908388
Study groupRoleWhat they receive
GORE Conformable TAG® Device Surgical ImplantExperimentalNot described
Receives: Device: GORE TAG® Thoracic Endoprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause Mortality Incidence Through 30 Days Post-treatment

    Measured: 30 Days Post-Treatment

  2. 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

    Measured: 1 month

Secondary outcomes (3)

  1. 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.

    Measured: Last available follow-up through 5 years

  2. Aortic Rupture

    Number of participants with thoracic aortic rupture

    Measured: Last available follow-up through 5 years

  3. 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.

    Measured: Last available follow-up through 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionFeb 2012
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00908388
Sponsor's protocol ID
TAG 08-01
Status last verified
Sep 2017
First submitted
3 Apr 2009
Last updated
27 Oct 2017
Data monitoring committee
Yes

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.

    PubMed 30598352

Questions about this trial

What is this clinical trial studying?

A study testing GORE TAG® Thoracic Endoprosthesis in people with Type B Aortic Dissection, run by W.L.Gore & Associates at 37 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality Incidence Through 30 Days Post-treatment (time frame: 30 Days Post-Treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00908388, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.

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