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A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection (ADSORB)

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ClinicalTrials.gov Identifier: NCT00742274
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : May 9, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections.

Condition or disease Intervention/treatment
Aortic Diseases Device: Gore TAG Endoprosthesis Other: Best Medical Therapy

Detailed Description:
Dissection of the aorta is a medical emergency requiring immediate surgery. Type B dissections are typically treated with surgery or endoluminal therapy when complications such as uncontrollable pain, organ ischemia, or aortic rupture are present. However, the treatment of patients with uncomplicated, acute type B dissections is controversial. Best medical therapy (BMT) is the standard of care in these cases since surgical repair offers no additional survival advantage. However, Endoluminal stent graft therapy with the GORE TAG Thoracic Endoprosthesis (GORE TAG device) may offer distinct advantages as an adjunct to medical therapy for uncomplicated acute type B dissection. The goal of endoluminal stent grafting is to cover the primary entry tear of the dissection to isolate the false lumen from blood flow and induce aortic remodeling.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized European Study Comparing Endoluminal Stent Grafting and Best Medical Therapy (BMT) to BMT Alone in the Treatment of Acute Uncomplicated Type B Aortic Dissection
Study Start Date : August 2008
Primary Completion Date : February 2012
Study Completion Date : October 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
TAG+BMT
Device: Gore TAG Endoprosthesis
Implant Gore TAG device with Best Medical therapy per physician discretion
Active Comparator: 2
BMT alone
Other: Best Medical Therapy
Best Medical therapy is regimen of antihypertensive medications used to maintain blood pressure below 125/80 mm/Hg throughout the entire follow-up period. Because BMT is assessed by blood pressure response to medication, specific medication regimens for each patient will differ. The typical regimen consists of 1 to 4 concomitant antihypertensive medications that may include angiotensin converting enzyme (ACE) inhibitors, alpha blockers, beta blockers, calcium channel blockers, diuretics, and/or vasodilators.


Outcome Measures

Primary Outcome Measures :
  1. Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation [ Time Frame: 1 year ]

    Subjects with any of the following met this composite outcome:

    • partial/no false lumen thrombosis
    • aortic rupture
    • aortic dilatation
    • lack of 1 year imaging (no image, incomplete image missing primary endpoint measurements, unevaluable image)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Presence of acute uncomplicated type B aortic dissection
  2. Able to tolerate endotracheal intubation and general anesthesia
  3. Maximum transverse diameter of the descending thoracic aorta < 55 mm and absence of descending thoracic aortic aneurysm, regardless of etiology.
  4. Arterial anatomy is appropriate for stent graft therapy

Exclusion Criteria:

  1. ASA classification = V
  2. Severe renal insufficiency defined as SVS risk renal status = 3
  3. Severe respiratory insufficiency defined as SVS risk pulmonary status = 3
  4. Presence of connective tissue disease
  5. Active infection or active vasculitides
  6. Positive pregnancy test
  7. Participation in another medical research study within 3 months of study enrollment
  8. Myocardial infarction or cerebrovascular accident within 6 weeks prior to study enrollment
  9. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass), or major surgery within 30 days of study enrollment
  10. History of drug abuse
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742274


Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Jan Brunkwall, MD, PhD Kilinkum der Universitat zu Koln