Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

Study Overview
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Brief Summary
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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.

Official Title
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Valiant® Thoracic Stent Graft With the Captivia Delivery System. Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

Conditions
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Aortic Dissection

Intervention / Treatment
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* Device: Valiant Thoracic Stent Graft with the Captivia Delivery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Subject signed an informed consent. Subject is at least 18 years old. Subject has an acute, complicated Type B aortic dissection with evidence of at least one of the following: Malperfusion (visceral, renal, spinal cord and/or lower limb ischemia) Visceral ischemia measured by either radiographic or clinical evidence. Renal ischemia measured by either radiographic or clinical evidence. Spinal cord ischemia measured by either radiographic or clinical evidence. Lower limb ischemia measured by either radiographic or clinical evidence. Rupture - Measured by radiographic or clinical evidence. Subject is hemodynamically stable. Subject's anatomy must meet all of the following anatomical criteria: Proximal landing zone aortic diameter must be between 20 mm and 44 mm; Centerline distance from distal margin of left CCA or in cases of bovine anatomy, innominate artery, to start of most proximal tear must be ≥ 20 mm; Subject has patent iliac or femoral arteries or can tolerate an iliac conduit that allows endovascular access to the dissection site with the delivery system of the appropriate sized device. Thoracic aortic dissection is confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) with 3-D reconstruction, and/or contrast enhanced magnetic resonance angiogram (MRA) obtained prior to the implant procedure. Exclusion Criteria Planned placement of the COVERED portion of the stent graft over the left carotid artery, or the celiac trunk. Subject has systemic infection. Subject is pregnant. Subject has received a previous stent or stent graft or previous surgical repair in the DTA. Subject has had a cerebral vascular accident (CVA) within 2 months. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion. Subject has a history of Marfan Syndrome or other connective tissue disorder. Subject is currently participating in an investigational drug or device clinical trial which would interfere with the endpoints and follow-ups of this study. Subject has a known allergy or intolerance to the device components. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment. Subject has a co-morbidity causing expected survival to be less than 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System<br> | Device: Valiant Thoracic Stent Graft with the Captivia Delivery System<br>* All subjects will be implanted with this device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cause Mortality. |  | Up to 30 days after the stent graft implant. | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic dissection, Endovascular aortic repair