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

Sponsored by:	W.L.Gore & Associates
Information provided by:	W.L.Gore & Associates
ClinicalTrials.gov Identifier:	NCT00742274

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

Drug Information available for: Calcium gluconate Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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 false lumen thrombosis, aortic rupture, and aortic dilatation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental TAG+BMT	Device: Gore TAG Endoprosthesis Implant Gore TAG device with Best Medical therapy per physician discretion
2: Active Comparator 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.

Arms

Assigned Interventions

1: Experimental

TAG+BMT

Device: Gore TAG Endoprosthesis

Implant Gore TAG device with Best Medical therapy per physician discretion

2: Active Comparator

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.

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:

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

Exclusion Criteria:

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

Contacts and Locations

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

Responsible Party:	W.L. Gore & Associates, inc ( Clinical Study Manager )
Study ID Numbers:	TAG 05-04
Study First Received:	August 25, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00742274
Health Authority:	Austria: Ethikkommission; Belgium: Institutional Review Board; Denmark: Ethics Committee; France: Institutional Ethical Committee; Germany: Ethics Commission; Italy: Ethics Committee; Netherlands: Independent Ethics Committee; Spain: Ethics Committee; Sweden: Regional Ethical Review Board; United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Calcium, Dietary
Aortic Diseases
Benzocaine
Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009