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

NCT ID: NCT00742274

Last Updated: 2013-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2013-10-31

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.

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.

Conditions

Aortic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

TAG+BMT

Group Type: EXPERIMENTAL

Gore TAG Endoprosthesis

Intervention Type: DEVICE

Implant Gore TAG device with Best Medical therapy per physician discretion

2

BMT alone

Group Type: ACTIVE_COMPARATOR

Best Medical Therapy

Intervention Type: 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.

Interventions

Gore TAG Endoprosthesis

Implant Gore TAG device with Best Medical therapy per physician discretion

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Brunkwall, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kilinkum der Universitat zu Koln

References

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.

Reference Type: DERIVED

PMID: 24962744 (View on PubMed)

Other Identifiers

TAG 05-04

Identifier Type: -

Identifier Source: org_study_id