Aortic Diseases
Conditions
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.
Interventions
DEVICEGore TAG Endoprosthesis
Implant Gore TAG device with Best Medical therapy per physician discretion
OTHERBest 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.
Sponsors
W.L.Gore & Associates
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAG Device + Best Medical Therapy (BMT) | 30 |
| BEST MEDICAL THERAPY (BMT) Alone | 31 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Removed for medical reasons | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | TAG Device + Best Medical Therapy (BMT) | BEST MEDICAL THERAPY (BMT) Alone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 12 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 19 Participants | 36 Participants |
| Age Continuous | 60.1 years STANDARD_DEVIATION 10.5 | 60.7 years STANDARD_DEVIATION 13.4 | 60.4 years STANDARD_DEVIATION 12 |
| Region of Enrollment Austria | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Denmark | 1 participants | 0 participants | 1 participants |
| Region of Enrollment France | 7 participants | 3 participants | 10 participants |
| Region of Enrollment Germany | 14 participants | 17 participants | 31 participants |
| Region of Enrollment Italy | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Netherlands | 3 participants | 3 participants | 6 participants |
| Region of Enrollment Sweden | 1 participants | 4 participants | 5 participants |
| Region of Enrollment United Kingdom | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Male | 21 Participants | 27 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 30 | 14 / 31 |
| serious Total, serious adverse events | 16 / 30 | 13 / 31 |
Outcome results
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)
Time frame: 1 year
Population: Intent to Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAG Device + Best Medical Therapy (BMT) | Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation | 15 participants |
| BEST MEDICAL THERAPY (BMT) Alone | Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation | 31 participants |
p-value: <0.001Chi-squared