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

W.L.Gore & Associates61 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Diseases

Interventions

Gore TAG EndoprosthesisDEVICE

Implant Gore TAG device with Best Medical therapy per physician discretion

Best Medical TherapyOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 1 year

Data from ClinicalTrials.gov

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