Valor II: The Valiant Thoracic Stent Graft System Clinical Study

Study Overview
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Brief Summary
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This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.

Detailed Description
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The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.

Official Title
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The Valiant Thoracic Stent Graft System. The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair.

Conditions
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Thoracic Aortic Aneurysm

Intervention / Treatment
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* Device: Valiant Thoracic Stent Graft System


Participation Criteria
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Eligibility Criteria
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The following inclusion/exclusion criteria was obtained from the study protocol. INCLUSION CRITERIA To be eligible for enrollment, a subject must meet all of the following inclusion criteria: Subject is between the age of 18 and 85. Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk [categories 0, 1, and 2] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure. Subject has a DTA that is: A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR Saccular aneurysm (penetrating atherosclerotic ulcer) Subject's anatomy must meet all of the following anatomical criteria: Subject's TAA must be ≥ 20 mm distal to the origin of the left common carotid artery and must be ≥ 20 mm proximal to the celiac artery; Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm; Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within four (4) months prior to the implant procedure. Subject is able and willing to comply with the protocol and undergo follow-up requirements. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study. Subject has patent iliac or femoral arteries or can tolerate a vascular conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate size device chosen for treatment. EXCLUSION CRITERIA To be eligible for enrollment, a subject cannot meet any of the following exclusion criteria: Planned placement of the COVERED portion of the stent graft requires implant to occur in zones 0 or 1. Subject has a thoracic aneurysm with a contained rupture. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration). Subject has a mycotic aneurysm or is suspected of having systemic infection. Subject has received a previous stent or stent graft or previous surgical repair in the DTA. Subject requires treatment of an infra-renal aneurysm at the time of implant. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion. Subject has had or plans to have a major surgical procedure within 30 days before or after the Valiant Stent Graft procedure. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure). Subject has had an MI or cerebral vascular accident (CVA) within 3 months. Subject is currently participating in an investigational drug or device clinical trial. 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 significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude him or her from receiving this treatment and the procedures and evaluations pre- and post-treatment, or a limited life expectancy of less than 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 System<br>160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study. | Device: Valiant Thoracic Stent Graft System<br>* Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).<br>* Other names: Valiant device; Valiant stent graft.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) | Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study. | 0 through 1825 days post treatment | 
| Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint) | Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak). | At 12-month post procedure | 
| Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > > | The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. > > Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks. | Within 12-months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant | Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness. | At implant | 
| Percentage of Participants That Experienced Perioperative Mortality | Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure. | Within 30 days post treatment | 
| Percentage of Participants That Experienced Paraplegia | Percentage of subjects that experienced paraplegia within 30 days post treatment | Within 30 days post treatment | 
| Percentage of Participants That Experienced Paraparesis | Percentage of subjects that experienced paraparesis within 30 days post treatment | Within 30 days post treatment | 
| Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge | Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment | Within 30 days post treatment | 
| Percentage of Participants That Experienced One or More Major Adverse Events | Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device | Within 30 days post treatment | 
| Percentage of Participants That Experienced Aneurysm-related Mortality | Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment | Within 12 months post treatment | 
| Percentage of Participants That Experience Aneurysm Rupture | Percentage of subjects that experience aneurysm rupture within 12 months post treatment | Within 12 months post treatment | 
| Percentage of Participants That Experienced Conversion to Open Surgical Repair | Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment | Within 12 months post treatment | 
| Percentage of Participants That Experienced Endoleak(s) | Percentage of subjects that experienced endoleak(s) of any type at 12 months | At 12 months | 
| Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak | Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months | Between 30 days and 12 months | 
| Percentage of Participants That Experienced Stent Graft Migration | Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations. | Within 12 months post treatment | 
| Percentage of Participants That Experience Loss of Stent Graft Patency | Percentage of subjects that experience loss of stent graft patency within 12 months post treatment | Within 12 months post treatment | 
| Percentage of Participants That Experienced One or More Major Adverse Events | Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment | Within 12 months post treatment | 
| Percentage of Participants That Died (All-cause Mortality) | Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Aneurysm-related Mortality | Percentage of subjects that experienced aneurysm-related within five years post implant | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Aneurysm Ruptures | Percentage of subjects that experienced aneurysm ruptures within five years post implant | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Conversions to Open Surgical Repair | Percentage of subjects that experienced conversions to open surgical repair within five years post implant | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Type I Endoleaks | Percentage of subjects that experienced type I endoleaks within five years post implant | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Type III Endoleaks | Percentage of subjects that experienced type III endoleaks within five years post implant | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Type IV Endoleaks | Percentage of subjects that experienced type IV endoleaks within five years post implant | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Secondary Endovascular Procedures | Percentage of subjects that experienced secondary endovascular procedures within five years post implant | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Stent Graft Migrations (Site Reported) | Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites | 0 through 1825 days post treatment | 
| Percentage of Participants That Experienced Loss of Stent Graft Patency | Percentage of subjects that experienced loss of stent graft patency within five years post implant | 0 through 1825 days post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracic Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft, Thoracic Aortic Aneurysm, Endovascular procedure, Descending Thoracic Aneurysm, Valiant Stent Graft System