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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valiant Thoracic Stent Graft with the Captivia Delivery System | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valiant Thoracic Stent Graft with the Captivia Delivery System | Device | All subjects will be implanted with this device |
|
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality. | Up to 30 days after the stent graft implant. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | at 12 months | |
| Subjects With Successful Delivery and Deployment of the Device. | At implant. | |
| Subjects With Coverage of Primary Tear |
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Inclusion Criteria
Proximal landing zone aortic diameter must be between 20 mm and 44 mm;
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Joseph E. Bavaria, M.D. | Univ. of Pennsylvania Health System | Principal Investigator |
| W. Anthony Lee, M.D., F.A.C.S | Lynn Heart Institute, Boca Raton Community Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Keck School of Medicine | Los Angeles | California | 90033 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32654872 | Derived | Bavaria JE, Brinkman WT, Hughes GC, Shah AS, Charlton-Ouw KM, Azizzadeh A, White RA. Five-year outcomes of endovascular repair of complicated acute type B aortic dissections. J Thorac Cardiovasc Surg. 2022 Feb;163(2):539-548.e2. doi: 10.1016/j.jtcvs.2020.03.162. Epub 2020 May 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Valiant Thoracic Stent Graft With the Captivia Delivery System | Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| At implant |
| Aortic Rupture | Within 30 days |
| Aortic Rupture | Within 12 months |
| Subjects With Secondary Endovascular Procedures | Through12 months |
| Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment | At 6 months |
| Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment | At 12 months |
| Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft | at 6 months |
| Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft | at 12 months |
| Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft | at 6 months |
| Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft | at 12 months |
| Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. | at 30 days |
| Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. | at 12 months |
| Los Angeles |
| California |
| 90048 |
| United States |
| Harbor UCLA | Torrance | California | 90502 | United States |
| Washington Hospital D.C. | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Northwestern Memorial | Chicago | Illinois | 60601 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| New York Presbyterian Weill Cornell | New York | New York | 10065 | United States |
| Novant Health Heart and Vascular Institute | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | United States |
| Heart Hospital Medical Center | Dallas | Texas | 75230 | United States |
| Baylor | Houston | Texas | 77030 | United States |
| Memorial Hermann Heart and Vascular Institute | Houston | Texas | 77030 | United States |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University MCV Richmond | Richmond | Virginia | 23298 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Valiant Thoracic Stent Graft With the Captivia Delivery System | Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | Based on number of ITT subjects with available data | Posted | Number | participants | Up to 30 days after the stent graft implant. |
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| Secondary | All-cause Mortality | Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up) | Posted | Number | participants | at 12 months |
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| Secondary | Subjects With Successful Delivery and Deployment of the Device. | Based on number of ITT subjects with available data | Posted | Number | participants | At implant. |
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| Secondary | Subjects With Coverage of Primary Tear | Based on number of ITT subjects with available data | Posted | Number | participants | At implant |
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| Secondary | Aortic Rupture | Based on number of ITT subjects with available data. | Posted | Number | participants | Within 30 days |
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| Secondary | Aortic Rupture | Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up) | Posted | Number | participants | Within 12 months |
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| Secondary | Subjects With Secondary Endovascular Procedures | Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn before the lower limit of the 12 months follow-up window or were lost to follow-up before the lower limit of the 12 months follow-up window. (One patient withdrew and one was lost to follow-up) | Posted | Number | participants | Through12 months |
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| Secondary | Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment | Based on number of ITT subjects with evaluable imaging data. | Posted | Number | participants | At 6 months |
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| Secondary | Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment | Based on number of ITT subjects with evaluable imaging data. | Posted | Number | participants | At 12 months |
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| Secondary | Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft | Based on number of ITT subjects with evaluable imaging data. | Posted | Number | participants | at 6 months |
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| Secondary | Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft | Based on number of ITT subjects with evaluable imaging data. | Posted | Number | participants | at 12 months |
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| Secondary | Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft | Based on number of ITT subjects with evaluable imaging data. | Posted | Number | participants | at 6 months |
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| Secondary | Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft | Based on number of ITT subjects with evaluable imaging data. | Posted | Number | participants | at 12 months |
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| Secondary | Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. | Based on number of ITT subjects with available data. | Posted | Number | participants | at 30 days |
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| Secondary | Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. | Based on number of ITT subjects with available data. Subjects were considered unevaluable if they were withdrawn or were lost to follow-up before the lower limit of the 12 mos follow-up window.One subject was lost to follow-up and one withdrew before 12 mos. One of these subjects experienced an AE before study exit and was included in the analysis, | Posted | Number | participants | at 12 months |
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12 months
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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 | 1. Dissection | Medtronic Dissection | 23 | 50 | 0 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Tamponade | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Continued Perfusion from a Branch Vessel requiring Treatment | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Incision Site Pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Nerve Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Stent-Graft Endoleak | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| White Blood Cell Count Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebral Ischaemia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Monoplegia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Paralysis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Spinal Cord Ischaemia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Aortic Aneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Aortic Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Intermittent Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Vascular Disorder | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Subclavian Artery Embolism | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Paraplegia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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The Principal Investigator (PI) and institution agree not to publish the results of the study until after the earliest of the following: a)conclusion of the study, b)the early termination of the study, c)at discretion and approval of the sponsor, or d)after sponsor confirms there will be no multicenter study publication, whichever occurs first. PI and institution further agree to submit to sponsor copies of any proposed publication or public presentation at least sixty days before dissemination.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Celeste Claudy - Study Lead | Medtronic Inc., Aortic and Peripheral Vascular | 763-514-0130 | celeste.m.claudy@medtronic.com |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
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