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Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft
This study is a prospective, multicenter, non-randomized single-arm study to assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GORE® Ascending Stent Graft | Experimental | Treatment with the GORE® Ascending Stent Graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® Ascending Stent Graft | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality at 30 Days Post-procedure | Number of subjects that die of any cause within 30 days post-procedure | 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Dissection Treatment (Technical Success) | Number of subjects with technical success defined as successful access to the aorta, successful deployment of the study device components, successful retrieval of the device delivery system, exclusion of the primary entry tear of the aortic dissection, and patency of the side branch device component, if used. | At removal of device deployment system, up to conclusion of procedure |
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Inclusion Criteria:
DeBakey Type I/II aortic dissection compatible with the treatment requirements of GORE® Ascending Stent Graft, including:
Able to undergo CT scan per protocol requirements to perform required case planning prior to endovascular procedure
High surgical risk, as determined by the implanting physician
Adequate vascular access via transfemoral or retroperitoneal approach
An Informed Consent Form signed by Subject or legally authorized representative
Able to comply with protocol requirements including follow-up
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California- Keck Medicine | Los Angeles | California | 90033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GORE® Ascending Stent Graft | Treatment with the GORE® Ascending Stent Graft GORE® Ascending Stent Graft |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GORE® Ascending Stent Graft | Treatment with the GORE® Ascending Stent Graft GORE® Ascending Stent Graft |
| 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 | All Cause Mortality at 30 Days Post-procedure | Number of subjects that die of any cause within 30 days post-procedure | Posted | Count of Participants | Participants | 30 days post-procedure |
|
|
Through 5 Years or Study Discontinuation/Completion
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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 | GORE® Ascending Stent Graft | Treatment with the GORE® Ascending Stent Graft GORE® Ascending Stent Graft |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clostridium Difficile Colities | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg Miller | W. L. Gore & Associates | 623-234-5910 | gmiller@wlgore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2021 | May 8, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months | Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee | 30 days, 6 months, and 12 months post procedure |
| Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | Individual Components include: All Cause Mortality, Myocardial Infarction (MI), and Severe Stroke. Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee. | 30 days, 6 months, and 12 months post procedure |
| Aorta-related Mortality | Assessed by reported adverse events and adjudicated by a Clinical Events Committee | 30 days post procedure |
| Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months | Assessed on CT scans within the defined visits windows 1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure | 30 days, 6 months, and 12 months post procedure |
| Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Assessed on CT scans within the defined visits windows: 1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure Definitions: Endoleak Type I (A and B): Endoleak arising at or from the prosthesis attachment site perfusing the treated region of the aorta. Endoleak Type IA: Endoleak at proximal aortic prosthesis attachment site. Endoleak Type IB: Endoleak at distal prosthesis attachment site. Endoleak Type II: Endoleak arising from a patent branch vessel of the excluded aorta perfusing the treated aorta, e.g., lumbar or inferior mesenteric branch. Endoleak Type III: Endoleak arising from the component junction(s) of the prosthesis or due to a defect in the graft material perfusing the treated region of the aorta. Endoleak Type IV: Endoleak arising through the graft fabric perfusing the treated region of the aorta. ***Endoleak categorizations have no directionality (i.e., cannot be considered better or worse)** | 30 days, 6 months, and 12 months post procedure |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Successful Dissection Treatment (Technical Success) | Number of subjects with technical success defined as successful access to the aorta, successful deployment of the study device components, successful retrieval of the device delivery system, exclusion of the primary entry tear of the aortic dissection, and patency of the side branch device component, if used. | Posted | Count of Participants | Participants | At removal of device deployment system, up to conclusion of procedure |
|
|
|
| Secondary | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) Assessed Through 30 Days, 6 Months, and 12 Months | Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee | Posted | Count of Participants | Participants | 30 days, 6 months, and 12 months post procedure |
|
|
|
| Secondary | Individual MACCE Components Through 30 Days, 6 Months, and 12 Months | Individual Components include: All Cause Mortality, Myocardial Infarction (MI), and Severe Stroke. Assessed by reported adverse events that meet the MACCE criteria and adjudicated by a Clinical Events Committee. | Posted | Count of Participants | Participants | 30 days, 6 months, and 12 months post procedure |
|
|
|
| Secondary | Aorta-related Mortality | Assessed by reported adverse events and adjudicated by a Clinical Events Committee | Posted | Count of Participants | Participants | 30 days post procedure |
|
|
|
| Secondary | Number of Participants With Device Migration Assessed Through 1 Month, 6 Months, and 12 Months | Assessed on CT scans within the defined visits windows 1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure | Posted | Count of Participants | Participants | 30 days, 6 months, and 12 months post procedure |
|
|
|
| Secondary | Endoleak Assessed Through 1 Month, 6 Months, and 12 Months | Assessed on CT scans within the defined visits windows: 1 Month: 15-59 days post procedure 6 Month: 60-242 days post procedure 12 Month: 243-546 days post procedure Definitions: Endoleak Type I (A and B): Endoleak arising at or from the prosthesis attachment site perfusing the treated region of the aorta. Endoleak Type IA: Endoleak at proximal aortic prosthesis attachment site. Endoleak Type IB: Endoleak at distal prosthesis attachment site. Endoleak Type II: Endoleak arising from a patent branch vessel of the excluded aorta perfusing the treated aorta, e.g., lumbar or inferior mesenteric branch. Endoleak Type III: Endoleak arising from the component junction(s) of the prosthesis or due to a defect in the graft material perfusing the treated region of the aorta. Endoleak Type IV: Endoleak arising through the graft fabric perfusing the treated region of the aorta. ***Endoleak categorizations have no directionality (i.e., cannot be considered better or worse)** | Posted | Count of Participants | Participants | 30 days, 6 months, and 12 months post procedure |
|
|
|
| 6 |
| 21 |
| 19 |
| 21 |
| 9 |
| 21 |
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | Systematic Assessment |
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| Sepsis | Infections and infestations | Systematic Assessment |
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| Urosepsis | Infections and infestations | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | Systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
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| Embolic Stroke | Nervous system disorders | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | Systematic Assessment |
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| Monoplegia | Nervous system disorders | Systematic Assessment |
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| Aortic Valve Incompetence | Cardiac disorders | Systematic Assessment |
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| Atrioventricular Block | Cardiac disorders | Systematic Assessment |
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| Atrioventricular Block Complete | Cardiac disorders | Systematic Assessment |
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| Ischaemic Cardiomyopathy | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | Systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | Systematic Assessment |
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| Cardiac Tamponade | Cardiac disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrilation | Cardiac disorders | Systematic Assessment |
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| Ventricular Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
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| Aortic Rupture | Vascular disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Enterocutaneous Fistula | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
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| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | Systematic Assessment |
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| Calculus Bladder | Renal and urinary disorders | Systematic Assessment |
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| Injury Associated with Device | General disorders | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Infusion Site Extravasation | General disorders | Systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | Systematic Assessment |
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| Stent-Graft Endoleak | General disorders | Systematic Assessment |
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| Device Placement Issue | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision Site Haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural Hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
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| Weaning Failure | Injury, poisoning and procedural complications | Systematic Assessment |
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| Arterial Puncture | Surgical and medical procedures | Systematic Assessment |
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| Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Pneumonia Aspiration | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
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| Blood Loss Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Sinus Tachycardia | Cardiac disorders | Systematic Assessment |
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| Accelerated Hypertension | Vascular disorders | Systematic Assessment |
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| Aortic Dissection | Vascular disorders | Systematic Assessment |
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| Shock | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Truncus Coeliacus Thrombosis | Gastrointestinal disorders | Systematic Assessment |
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| Gastrointestinal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Retroperitoneal Haematoma | Gastrointestinal disorders | Systematic Assessment |
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| Adverse Drug Reaction | General disorders | Systematic Assessment |
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| Stent-Graft Endoleak | General disorders | Systematic Assessment |
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| Device Placement Issue | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision Site Swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| Title | Measurements |
|---|---|
|
| Myocardial Infarction - 30 Days |
|
| Myocardial Infarction - 6 Months (183 Days) |
|
| Myocardial Infarction - One Year (365 Days) |
|
| Severe Stroke - 30 Days |
|
| Severe Stroke - 6 Months (183 Days) |
|
| Severe Stroke - One Year (365 Days) |
|
| Title |
|---|
| Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Type IA Endoleak - 1 Month |
|
| Type IA Endoleak - 6 Month |
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| Type IA Endoleak - 1 Year |
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| Type IB Endoleak - 1 Month |
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| Type IB Endoleak - 6 Month |
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| Type IB Endoleak - 12 Month |
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| Type II Endoleak - 1 Month |
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| Type II Endoleak - 6 Month |
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| Type II Endoleak - 12 Month |
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| Type III Endoleak - 1 Month |
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| Type III Endoleak - 6 Month |
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| Type III Endoleak - 12 Month |
|
| Type IV Endoleak - 1 Month |
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| Type IV Endoleak - 6 Month |
|
| Type IV Endoleak - 12 Month |
|