Trial Outcomes & Findings for A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection (NCT NCT00742274)
NCT ID: NCT00742274
Last Updated: 2013-12-04
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
1 year
Results posted on
2013-12-04
Participant Flow
Participant milestones
| Measure |
TAG Device + Best Medical Therapy (BMT)
TAG+BMT
|
Best Medical Therapy (BMT) Alone
BMT alone
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
TAG Device + Best Medical Therapy (BMT)
TAG+BMT
|
Best Medical Therapy (BMT) Alone
BMT alone
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Removed for medical reasons
|
1
|
1
|
Baseline Characteristics
A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection
Baseline characteristics by cohort
| Measure |
TAG Device + Best Medical Therapy (BMT)
n=30 Participants
|
BEST MEDICAL THERAPY (BMT) Alone
n=31 Participants
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age Continuous
|
60.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
60.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent to Treat (ITT)
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)
Outcome measures
| Measure |
TAG Device + Best Medical Therapy (BMT)
n=30 Participants
|
BEST MEDICAL THERAPY (BMT) Alone
n=31 Participants
|
|---|---|---|
|
Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation
|
15 participants
|
31 participants
|
Adverse Events
TAG Device + Best Medical Therapy (BMT)
Serious events: 16 serious events
Other events: 19 other events
Deaths: 0 deaths
BEST MEDICAL THERAPY (BMT) Alone
Serious events: 13 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAG Device + Best Medical Therapy (BMT)
n=30 participants at risk
|
BEST MEDICAL THERAPY (BMT) Alone
n=31 participants at risk
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.3%
1/30
|
0.00%
0/31
|
|
Cardiac disorders
Angina pectoris
|
3.3%
1/30
|
0.00%
0/31
|
|
Cardiac disorders
Tachyarrhythmia
|
3.3%
1/30
|
0.00%
0/31
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/30
|
3.2%
1/31
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/30
|
3.2%
1/31
|
|
Gastrointestinal disorders
Mesenteric vascular insufficiency
|
0.00%
0/30
|
3.2%
1/31
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/30
|
3.2%
1/31
|
|
General disorders
Death
|
3.3%
1/30
|
0.00%
0/31
|
|
General disorders
Device deployment issue
|
6.7%
2/30
|
0.00%
0/31
|
|
General disorders
Stent malfunction
|
6.7%
2/30
|
0.00%
0/31
|
|
General disorders
Stent-graft endoleak
|
3.3%
1/30
|
0.00%
0/31
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/30
|
3.2%
1/31
|
|
Infections and infestations
Pneumonia
|
0.00%
0/30
|
3.2%
1/31
|
|
Infections and infestations
Staphylococcal infection
|
3.3%
1/30
|
0.00%
0/31
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30
|
3.2%
1/31
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
3.3%
1/30
|
0.00%
0/31
|
|
Investigations
Blood creatinine increased
|
3.3%
1/30
|
3.2%
1/31
|
|
Investigations
Transaminases increased
|
3.3%
1/30
|
0.00%
0/31
|
|
Investigations
Troponin T increased
|
3.3%
1/30
|
0.00%
0/31
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30
|
0.00%
0/31
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30
|
3.2%
1/31
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/30
|
3.2%
1/31
|
|
Nervous system disorders
Carotid artery dissection
|
3.3%
1/30
|
0.00%
0/31
|
|
Nervous system disorders
Paraplegia
|
3.3%
1/30
|
0.00%
0/31
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/30
|
3.2%
1/31
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/30
|
3.2%
1/31
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/30
|
3.2%
1/31
|
|
Surgical and medical procedures
Urostomy
|
3.3%
1/30
|
0.00%
0/31
|
|
Vascular disorders
Aortic dilatation
|
6.7%
2/30
|
12.9%
4/31
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/30
|
3.2%
1/31
|
|
Vascular disorders
Aortic intramural haematoma
|
0.00%
0/30
|
3.2%
1/31
|
|
Vascular disorders
Collateral circulation
|
0.00%
0/30
|
3.2%
1/31
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/30
|
3.2%
1/31
|
|
Vascular disorders
Peripheral artery aneurysm
|
3.3%
1/30
|
0.00%
0/31
|
Other adverse events
| Measure |
TAG Device + Best Medical Therapy (BMT)
n=30 participants at risk
|
BEST MEDICAL THERAPY (BMT) Alone
n=31 participants at risk
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
10.0%
3/30
|
6.5%
2/31
|
|
General disorders
Fatigue
|
6.7%
2/30
|
0.00%
0/31
|
|
General disorders
Pyrexia
|
6.7%
2/30
|
0.00%
0/31
|
|
General disorders
Stent-graft endoleak
|
6.7%
2/30
|
0.00%
0/31
|
|
Investigations
Blood pressure abnormal
|
23.3%
7/30
|
12.9%
4/31
|
|
Investigations
Blood pressure increased
|
10.0%
3/30
|
9.7%
3/31
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
2/30
|
0.00%
0/31
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
2/30
|
0.00%
0/31
|
|
Vascular disorders
Hypertension
|
16.7%
5/30
|
19.4%
6/31
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place