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

NCT00742274 | Completed Results DMC

• 1 other identifier: TAG 05-04
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Diseases

Outcome Measures

Primary Outcomes (1)

• Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation

  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)

  1 year

Study Arms (2)

1

EXPERIMENTAL

TAG+BMT

Device: Gore TAG Endoprosthesis

2

ACTIVE COMPARATOR

BMT alone

Other: Best Medical Therapy

Interventions

Gore TAG Endoprosthesis DEVICE

Implant Gore TAG device with Best Medical therapy per physician discretion

1

Best Medical Therapy OTHER

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.

2

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

You may not qualify if:

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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Related Publications (1)

• Brunkwall J, Kasprzak P, Verhoeven E, Heijmen R, Taylor P; ADSORB Trialists; Alric P, Canaud L, Janotta M, Raithel D, Malina W, Resch T, Eckstein HH, Ockert S, Larzon T, Carlsson F, Schumacher H, Classen S, Schaub P, Lammer J, Lonn L, Clough RE, Rampoldi V, Trimarchi S, Fabiani JN, Bockler D, Kotelis D, Bockler D, Kotelis D, von Tenng-Kobligk H, Mangialardi N, Ronchey S, Dialetto G, Matoussevitch V. Endovascular repair of acute uncomplicated aortic type B dissection promotes aortic remodelling: 1 year results of the ADSORB trial. Eur J Vasc Endovasc Surg. 2014 Sep;48(3):285-91. doi: 10.1016/j.ejvs.2014.05.012. Epub 2014 Jun 22.

  PMID: 24962744 DERIVED

MeSH Terms

Conditions

Aortic Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jennifer Gorman
• Organization: W.L. Gore and Associates

jgorman@wlgore.com

928-864-3381

Study Officials

• Jan Brunkwall, MD, PhD

  Kilinkum der Universitat zu Koln

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 27, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: October 1, 2013
• Last Updated: December 4, 2013
• Results First Posted: May 9, 2013

Record last verified: 2013-11