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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00742274
First received: August 25, 2008
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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 Intervention
Aortic Diseases
Device: Gore TAG Endoprosthesis
Other: Best Medical Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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)


Enrollment: 61
Study Start Date: August 2008
Study Completion Date: October 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TAG+BMT
Device: Gore TAG Endoprosthesis
Implant Gore TAG device with Best Medical therapy per physician discretion
Other Name: Gore TAG Endoprosthesis
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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742274

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

No publications provided by W.L.Gore & Associates

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00742274     History of Changes
Other Study ID Numbers: TAG 05-04
Study First Received: August 25, 2008
Results First Received: March 14, 2013
Last Updated: November 8, 2013
Health Authority: Austria: Ethikkommission
Denmark: Ethics Committee
France: Institutional Ethical Committee
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Independent Ethics Committee
Sweden: Regional Ethical Review Board
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014