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Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conformable GORE® TAG® Thoracic Endoprosthesis | Device | Thoracic Endoprosthesis |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Entry Tear Exclusion | Number of subjects who achieved the primary entry tear exclusion | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
| Aortic Rupture | Number of subjects with Aortic Rupture | Procedure through 5 years (Day 0-2006) |
| Major Device-related Adverse Events | Number of subjects with major device-related adverse events | Procedure through 5 years (Day 0-2006) |
| Secondary Intervention Treatment | Incidence rate of secondary intervention treatment | Post-procedure through 5 years (Day 1-2006) |
| Change in Minimum True Lumen Diameter Adjacent to Treated Segment | Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
| Change in Minimum True Lumen Diameter Distal to Treated Segment | Change in minimum true lumen diameter distal to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
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Inclusion Criteria for Acute, Complicated Stanford Type B Aortic Dissection:
Inclusion Criteria for Traumatic Aortic Transection:
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Patients with acute, complicated Stanford Type B aortic dissection and patients with traumatic aortic transection treated using Gore CTAG.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dissection | Acute complicated Stanford type B dissection: Patients are enrolled and surveyed if the device is used in patients with complicated acute Stanford Type B aortic dissection at sites that contracted for this survey |
| FG001 | Trauma | Traumatic thoracic aortic injury: Patients are enrolled and surveyed if the device is used in patients with Traumatic thoracic aortic injury at sites that contracted for this survey |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dissection | Acute complicated Stanford type B dissection |
| BG001 | Trauma | Traumatic thoracic aortic injury |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Missing Data for Some 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 | Primary Entry Tear Exclusion | Number of subjects who achieved the primary entry tear exclusion | Patients with acute complicated Stanford type B dissection with evaluable result. (Not a protocol-defined endpoint for trauma arm and therefore not evaluated) | Posted | Count of Participants | Participants | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
|
|
5 years (Post-operative day 0-2006)
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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 | Dissection | Acute complicated Stanford type B dissection | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic Rupture | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charee Robe | W.L. Gore & Associates | 928-864-4048 | crobe@wlgore.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 31, 2020 | Jun 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2016 | Apr 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D000094629 | Dissection, Thoracic Aorta |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Change in Maximum False Lumen Diameter Adjacent to Treated Segment | Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
| Change in Maximum False Lumen Diameter Distal to Treated Segment | Change in maximum false lumen diameter distal to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
| Change in Maximum Lesion Diameter | Change in maximum lesion diameter at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | At each follow-up visit from 6 months through 5 years: 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
| BG002 |
| Total |
Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Missing Data for Some Participants | Median | Full Range | cm |
|
| Weight | Missing Data for Some Participants | Median | Full Range | kg |
|
| American Society of Anesthesiologists (ASA) Classification | ASA I - Healthy patient for elective operation ASA II - Patient with mild systemic disease limits activity but is not incapacitating ASA III - Patient with severe systemic disease that is constant threat of life, limits activity but is not incapacitating ASA IV - Patient with incapacitating disease that is a constant threat of life ASA V - Moribund patient not expected to live 24 hours with or without operation | Count of Participants | Participants |
|
| Pulmonary Disease | Count of Participants | Participants |
|
| Renal Disease | Count of Participants | Participants |
|
| Cerebrovascular Disease | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Prior Descending Thoracic Aorta Repair | Count of Participants | Participants |
|
| At Risk for Graft Infection | Count of Participants | Participants |
|
| Persistent Refractory Shock | Count of Participants | Participants |
|
| Bowel Necrosis | Count of Participants | Participants |
|
| Degenerative Connective Tissue Disease | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Aortic Rupture | Number of subjects with Aortic Rupture | Subjects with acute complicated Stanford type B dissection. (Not a protocol-defined endpoint for trauma arm and therefore not evaluated) | Posted | Count of Participants | Participants | Procedure through 5 years (Day 0-2006) |
|
|
|
| Primary | Major Device-related Adverse Events | Number of subjects with major device-related adverse events | Posted | Count of Participants | Participants | Procedure through 5 years (Day 0-2006) |
|
|
|
| Primary | Secondary Intervention Treatment | Incidence rate of secondary intervention treatment | Posted | Count of Participants | Participants | Post-procedure through 5 years (Day 1-2006) |
|
|
|
| Primary | Change in Minimum True Lumen Diameter Adjacent to Treated Segment | Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | Patients with acute complicated Stanford type B dissection with evaluable result. (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm) | Posted | Count of Participants | Participants | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
|
|
|
| Primary | Change in Minimum True Lumen Diameter Distal to Treated Segment | Change in minimum true lumen diameter distal to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm) | Posted | Count of Participants | Participants | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
|
|
|
| Primary | Change in Maximum False Lumen Diameter Adjacent to Treated Segment | Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm) | Posted | Count of Participants | Participants | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
|
|
|
| Primary | Change in Maximum False Lumen Diameter Distal to Treated Segment | Change in maximum false lumen diameter distal to treated segment at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm) | Posted | Count of Participants | Participants | At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
|
|
|
| Primary | Change in Maximum Lesion Diameter | Change in maximum lesion diameter at each follow-up visit: Decrease (>=5mm) vs No change vs Increase (>=5mm) | Subjects with Traumatic thoracic aortic injury. (Outcome not applicable for dissection arm - see Outcome Measures #5-8 for change in true/false lumen diameter for the dissection arm) | Posted | Count of Participants | Participants | At each follow-up visit from 6 months through 5 years: 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days) |
|
|
|
| 43 |
| 17 |
| 43 |
| 0 |
| 43 |
| EG001 | Trauma | Traumatic thoracic aortic injury | 1 | 12 | 1 | 12 | 0 | 12 |
| New Aortic Dissection | Vascular disorders | Systematic Assessment |
|
| False Lumen Enlargement (>=5mm) | Vascular disorders | Systematic Assessment |
|
| Atelactasis/Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Bowel Ischemia | Gastrointestinal disorders | Systematic Assessment |
|
| Other Bowel Complication | Gastrointestinal disorders | Systematic Assessment |
|
| Other Vascular Complication | Vascular disorders | Systematic Assessment |
|
| Paraplegia/Paraparesis | Nervous system disorders | Systematic Assessment |
|
| Prosthesis Infection | Infections and infestations | Systematic Assessment |
|
| Other Infection | Infections and infestations | Systematic Assessment |
|
| Other Complications (not device complication) | General disorders | Systematic Assessment |
|
| Endoleak Type Ia | Vascular disorders | Systematic Assessment |
|
| Endoleak Type III | Vascular disorders | Systematic Assessment |
|
| Endoleak, Other | Vascular disorders | Systematic Assessment |
|
The PI is required to obtain written permission from the Sponsor prior to publishing trial results.
| D001018 |
| Aortic Diseases |
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
| ASA III |
|
| ASA IV |
|
| ASA V |
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| Increase |
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| 6 Months |
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| 12 Months |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| Increase |
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| 6 Months |
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| 12 Months |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| Increase |
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| 6 Months |
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| 12 Months |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| Increase |
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| 6 Months |
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| 12 Months |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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| Increase |
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| 12 Months |
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| 24 Months |
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| 36 Months |
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| 48 Months |
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| 60 Months |
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