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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | TAG+BMT |
|
| 2 | Active Comparator | BMT alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gore TAG Endoprosthesis | Device | Implant Gore TAG device with Best Medical therapy per physician discretion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation | Subjects with any of the following met this composite outcome:
| 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Brunkwall, MD, PhD | Kilinkum der Universitat zu Koln | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24962744 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | TAG Device + Best Medical Therapy (BMT) | TAG+BMT |
| FG001 | Best Medical Therapy (BMT) Alone | BMT alone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TAG Device + Best Medical Therapy (BMT) | |
| BG001 | BEST MEDICAL THERAPY (BMT) Alone | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite of Partial or No False Lumen Thrombosis, Aortic Rupture, and Aortic Dilatation | Subjects with any of the following met this composite outcome:
| Intent to Treat (ITT) | Posted | Number | participants | 1 year |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TAG Device + Best Medical Therapy (BMT) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Gorman | W.L. Gore and Associates | 928-864-3381 | jgorman@wlgore.com |
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| ID | Term |
|---|---|
| D001018 | Aortic Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Best Medical Therapy | 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. |
|
| Removed for medical reasons |
|
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
|
| 16 |
| 30 |
| 19 |
| 30 |
| EG001 | BEST MEDICAL THERAPY (BMT) Alone | 13 | 31 | 14 | 31 |
| Angina pectoris | Cardiac disorders |
|
| Tachyarrhythmia | Cardiac disorders |
|
| Abdominal pain upper | Gastrointestinal disorders |
|
| Intestinal obstruction | Gastrointestinal disorders |
|
| Mesenteric vascular insufficiency | Gastrointestinal disorders |
|
| Pancreatitis | Gastrointestinal disorders |
|
| Death | General disorders |
|
| Device deployment issue | General disorders |
|
| Stent malfunction | General disorders |
|
| Stent-graft endoleak | General disorders |
|
| Hydrocholecystis | Hepatobiliary disorders |
|
| Pneumonia | Infections and infestations |
|
| Staphylococcal infection | Infections and infestations |
|
| Urinary tract infection | Infections and infestations |
|
| Post procedural haematoma | Injury, poisoning and procedural complications |
|
| Blood creatinine increased | Investigations |
|
| Transaminases increased | Investigations |
|
| Troponin T increased | Investigations |
|
| Dehydration | Metabolism and nutrition disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Carotid artery dissection | Nervous system disorders |
|
| Paraplegia | Nervous system disorders |
|
| Transient ischaemic attack | Nervous system disorders |
|
| Renal failure | Renal and urinary disorders |
|
| Bronchopneumopathy | Respiratory, thoracic and mediastinal disorders |
|
| Urostomy | Surgical and medical procedures |
|
| Aortic dilatation | Vascular disorders |
|
| Aortic dissection | Vascular disorders |
|
| Aortic intramural haematoma | Vascular disorders |
|
| Collateral circulation | Vascular disorders |
|
| Deep vein thrombosis | Vascular disorders |
|
| Peripheral artery aneurysm | Vascular disorders |
|
| Fatigue | General disorders |
|
| Pyrexia | General disorders |
|
| Stent-graft endoleak | General disorders |
|
| Blood pressure abnormal | Investigations |
|
| Blood pressure increased | Investigations |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
| Hypertension | Vascular disorders |
|
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