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

Aortic Diseases Clinical Trial

— ADSORB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742274
• Other study ID #: TAG 05-04
• Status: Completed
• Phase: N/A
• First received: August 25, 2008
• Last updated: November 8, 2013
• Start date: August 2008
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionDenmark: Ethics CommitteeFrance: Institutional Ethical CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteeSweden: Regional Ethical Review BoardUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Diseases

Intervention

Device:
• Gore TAG Endoprosthesis
Implant Gore TAG device with Best Medical therapy per physician discretion

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No