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

Primary Purpose

Aortic Diseases

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Gore TAG Endoprosthesis

Best Medical Therapy

About this trial

This is an interventional treatment trial for Aortic Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

TAG+BMT

BMT alone

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT00742274

First Posted

August 25, 2008

Last Updated

November 8, 2013

Sponsor

W.L.Gore & Associates

1. Study Identification

Unique Protocol Identification Number

NCT00742274

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

W.L.Gore & Associates

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

TAG+BMT

Arm Title

Arm Type

Active Comparator

Arm Description

BMT alone

Intervention Type

Device

Intervention Name(s)

Gore TAG Endoprosthesis

Intervention Description

Implant Gore TAG device with Best Medical therapy per physician discretion

Intervention Type

Other

Intervention Name(s)

Best Medical Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Brunkwall, MD, PhD

Organizational Affiliation

Kilinkum der Universitat zu Koln

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

24962744

Citation

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. Erratum In: Eur J Vasc Endovasc Surg. 2015 Jul;50(1):130. Bockler, D [removed]; von Tenng-Kobligk, H [corrected to von Tengg-Kobligk, H].

Results Reference

derived

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

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