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

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00742274
• Collaborator: (none)
• Enrollment: 61
• Arms: 2
• Duration (Months): 62

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Diseases	Device: Gore TAG Endoprosthesis; Other: Best Medical Therapy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2008
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 TAG+BMT	Device: Gore TAG Endoprosthesis; Implant Gore TAG device with Best Medical therapy per physician discretion
Active Comparator: 2 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.

Outcome Measures

Primary Outcome Measures

1. Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation [1 year]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

• Principal Investigator: Jan Brunkwall, MD, PhD, Kilinkum der Universitat zu Koln

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT00742274
• Other Study ID Numbers: TAG 05-04
• First Posted: Aug 27, 2008
• Last Update Posted: Dec 4, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Aortic Diseases

Study Results

Participant Flow

Arm/Group Title	TAG Device + Best Medical Therapy (BMT)	Best Medical Therapy (BMT) Alone
Arm/Group Description	TAG+BMT	BMT alone
Period Title: Overall Study
STARTED	30	31
COMPLETED	27	28
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	TAG Device + Best Medical Therapy (BMT)	BEST MEDICAL THERAPY (BMT) Alone	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	30	31	61
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 56.7%	19 61.3%	36 59%
>=65 years	13 43.3%	12 38.7%	25 41%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.1 (10.5)	60.7 (13.4)	60.4 (12.0)
Sex: Female, Male (Count of Participants)
Female	9 30%	4 12.9%	13 21.3%
Male	21 70%	27 87.1%	48 78.7%
Region of Enrollment (participants) [Number]
Austria	1 3.3%	0 0%	1 1.6%
Denmark	1 3.3%	0 0%	1 1.6%
France	7 23.3%	3 9.7%	10 16.4%
Germany	14 46.7%	17 54.8%	31 50.8%
Italy	2 6.7%	2 6.5%	4 6.6%
Netherlands	3 10%	3 9.7%	6 9.8%
Sweden	1 3.3%	4 12.9%	5 8.2%
United Kingdom	1 3.3%	2 6.5%	3 4.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT)

Arm/Group Title	TAG Device + Best Medical Therapy (BMT)	BEST MEDICAL THERAPY (BMT) Alone
Arm/Group Description
Measure Participants	30	31
Number [participants]	15 50%	31 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	TAG Device + Best Medical Therapy (BMT), BEST MEDICAL THERAPY (BMT) Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	TAG Device + Best Medical Therapy (BMT)		BEST MEDICAL THERAPY (BMT) Alone
Arm/Group Description
All Cause Mortality
	TAG Device + Best Medical Therapy (BMT)		BEST MEDICAL THERAPY (BMT) Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	TAG Device + Best Medical Therapy (BMT)		BEST MEDICAL THERAPY (BMT) Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/30 (53.3%)		13/31 (41.9%)
Blood and lymphatic system disorders
Anaemia	1/30 (3.3%)		0/31 (0%)
Cardiac disorders
Angina pectoris	1/30 (3.3%)		0/31 (0%)
Tachyarrhythmia	1/30 (3.3%)		0/31 (0%)
Gastrointestinal disorders
Abdominal pain upper	0/30 (0%)		1/31 (3.2%)
Intestinal obstruction	0/30 (0%)		1/31 (3.2%)
Mesenteric vascular insufficiency	0/30 (0%)		1/31 (3.2%)
Pancreatitis	0/30 (0%)		1/31 (3.2%)
General disorders
Death	1/30 (3.3%)		0/31 (0%)
Device deployment issue	2/30 (6.7%)		0/31 (0%)
Stent malfunction	2/30 (6.7%)		0/31 (0%)
Stent-graft endoleak	1/30 (3.3%)		0/31 (0%)
Hepatobiliary disorders
Hydrocholecystis	0/30 (0%)		1/31 (3.2%)
Infections and infestations
Pneumonia	0/30 (0%)		1/31 (3.2%)
Staphylococcal infection	1/30 (3.3%)		0/31 (0%)
Urinary tract infection	0/30 (0%)		1/31 (3.2%)
Injury, poisoning and procedural complications
Post procedural haematoma	1/30 (3.3%)		0/31 (0%)
Investigations
Blood creatinine increased	1/30 (3.3%)		1/31 (3.2%)
Transaminases increased	1/30 (3.3%)		0/31 (0%)
Troponin T increased	1/30 (3.3%)		0/31 (0%)
Metabolism and nutrition disorders
Dehydration	1/30 (3.3%)		0/31 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/30 (3.3%)		1/31 (3.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	0/30 (0%)		1/31 (3.2%)
Nervous system disorders
Carotid artery dissection	1/30 (3.3%)		0/31 (0%)
Paraplegia	1/30 (3.3%)		0/31 (0%)
Transient ischaemic attack	0/30 (0%)		1/31 (3.2%)
Renal and urinary disorders
Renal failure	0/30 (0%)		1/31 (3.2%)
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy	0/30 (0%)		1/31 (3.2%)
Surgical and medical procedures
Urostomy	1/30 (3.3%)		0/31 (0%)
Vascular disorders
Aortic dilatation	2/30 (6.7%)		4/31 (12.9%)
Aortic dissection	0/30 (0%)		1/31 (3.2%)
Aortic intramural haematoma	0/30 (0%)		1/31 (3.2%)
Collateral circulation	0/30 (0%)		1/31 (3.2%)
Deep vein thrombosis	0/30 (0%)		1/31 (3.2%)
Peripheral artery aneurysm	1/30 (3.3%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	TAG Device + Best Medical Therapy (BMT)		BEST MEDICAL THERAPY (BMT) Alone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/30 (63.3%)		14/31 (45.2%)
Cardiac disorders
Angina pectoris	3/30 (10%)		2/31 (6.5%)
General disorders
Fatigue	2/30 (6.7%)		0/31 (0%)
Pyrexia	2/30 (6.7%)		0/31 (0%)
Stent-graft endoleak	2/30 (6.7%)		0/31 (0%)
Investigations
Blood pressure abnormal	7/30 (23.3%)		4/31 (12.9%)
Blood pressure increased	3/30 (10%)		3/31 (9.7%)
Musculoskeletal and connective tissue disorders
Back pain	2/30 (6.7%)		0/31 (0%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	2/30 (6.7%)		0/31 (0%)
Vascular disorders
Hypertension	5/30 (16.7%)		6/31 (19.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.