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To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA)
> Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE CTAG Device | Experimental | The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE CTAG Device | Device | Endovascular aortic stent-graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment | Treatment through 1 month post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. | Treatment through 1 month post procedure | |
| Procedure Time (Minutes) | Total time in minutes required for surgical device implantation. |
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Inclusion Criteria:>
1. Presence of DTA aneurysm deemed to warrant surgical repair >
Exclusion Criteria:>
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| Name | Affiliation | Role |
|---|---|---|
| William D Jordan, Dr. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Medical Center | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34022380 | Derived | Jordan WD, Desai N, Letter AJ, Matsumura JS. Long-term outcomes of the conformable TAG thoracic endoprosthesis in a prospective multicenter trial. J Vasc Surg. 2021 Nov;74(5):1491-1498. doi: 10.1016/j.jvs.2021.04.063. Epub 2021 May 20. | |
| 30598352 | Derived | Panthofer AM, Olson SL, Harris DG, Matsumura JS. Derivation and validation of thoracic sarcopenia assessment in patients undergoing thoracic endovascular aortic repair. J Vasc Surg. 2019 May;69(5):1379-1386. doi: 10.1016/j.jvs.2018.08.180. Epub 2018 Dec 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE CTAG Device | The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE CTAG Device | The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment | Posted | Number | participants | Treatment through 1 month post treatment |
|
|
5 years
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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 | CTAG Device Aneurysm Subjects | 19 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abe Letter | W.L. Gore & Associates | 928-864-3113 | aletter@wlgore.com |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Initial Device Implant Procedure During Index Hospitalization |
| Operative Blood Loss (mL) | Blood loss in mL during initial device implantation procedure | Initial Device Implant Procedure During Index Hospitalization |
| Days of Convalescence Stay in an Intensive Care Unit | Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation | During the Index Hospitalization |
| Total Length of Hospital Stay (Days) | Total days of hospital stay during the initial hospitalization for implantation of device | Total Duration of the Index Hospitalization |
| Time in Days to Return to Normal Daily Activities | This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis. | Average time within one month window |
| Procedural Survival | Subjects who survived the index procedure | Initial Device Implant Procedure During Index Hospitalization |
| Intensive Care Unit (ICU) Stay | Subjects admitted to ICU during index hospitalization | Initial Device Implant Index Hospitalization |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. | Posted | Number | participants | Treatment through 1 month post procedure |
|
|
|
| Secondary | Procedure Time (Minutes) | Total time in minutes required for surgical device implantation. | Posted | Median | 95% Confidence Interval | Minutes | Initial Device Implant Procedure During Index Hospitalization |
|
|
|
| Secondary | Operative Blood Loss (mL) | Blood loss in mL during initial device implantation procedure | Posted | Median | Standard Deviation | mL | Initial Device Implant Procedure During Index Hospitalization |
|
|
|
| Secondary | Days of Convalescence Stay in an Intensive Care Unit | Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation | Posted | Number | participants | During the Index Hospitalization |
|
|
|
| Secondary | Total Length of Hospital Stay (Days) | Total days of hospital stay during the initial hospitalization for implantation of device | Posted | Median | Full Range | Days | Total Duration of the Index Hospitalization |
|
|
|
| Secondary | Time in Days to Return to Normal Daily Activities | This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis. | Posted | Median | Full Range | Days | Average time within one month window |
|
|
|
| Secondary | Procedural Survival | Subjects who survived the index procedure | Posted | Count of Participants | Participants | Initial Device Implant Procedure During Index Hospitalization |
|
|
|
| Secondary | Intensive Care Unit (ICU) Stay | Subjects admitted to ICU during index hospitalization | Posted | Count of Participants | Participants | Initial Device Implant Index Hospitalization |
|
|
|
| 37 |
| 51 |
| 42 |
| 51 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Neurogenic bowel | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Multimorbidity | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Stent-graft endoleak | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cholangitis acute | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Gallbladder necrosis | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Necrotising fasciitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Sepsis syndrome | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Arterial injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Lung carcinoma cell type unspecified stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Ureteral neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Spinal cord disorder | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Spinal cord ischaemia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Spinal epidural haematoma | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Vocal cord paralysis | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Accelerated hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Aortic dissection rupture | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypoperfusion | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Iliac artery occlusion | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Stent-graft endoleak | General disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
Gore has the right to review disclosures, requesting a delay of less than 90 days. Each investigator will postpone single center publications until after disclosure of multi-center data, less than 12 months from study completion/termination at all participating sites.