Clinical trial NCT00413231: Valor II: The Valiant Thoracic Stent Graft System Clinical Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Aortic Aneurysm
Keywords: Thoracic Aneurysm
Endovascular Aortic Repair (EVAR)
Endovascular Stent Graft
Endograft
Thoracic Aortic Aneurysm
Endovascular procedure
Descending Thoracic Aneurysm
Valiant Stent Graft System
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2006-12-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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:

1. Subject is between the age of 18 and 85.
2. 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
3. If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure.
4. Subject has a DTA that is:

   1. A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is \> 2 times the diameter of the non-aneurysmal thoracic aorta;

      AND/OR
   2. Saccular aneurysm (penetrating atherosclerotic ulcer)
5. Subject's anatomy must meet all of the following anatomical criteria:

   1. 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;
   2. Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm;
   3. Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length.
6. 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.
7. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
8. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
9. 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:

1. Planned placement of the COVERED portion of the stent graft requires implant to occur in zones 0 or 1.
2. Subject has a thoracic aneurysm with a contained rupture.
3. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
4. Subject has a mycotic aneurysm or is suspected of having systemic infection.
5. Subject has received a previous stent or stent graft or previous surgical repair in the DTA.
6. Subject requires treatment of an infra-renal aneurysm at the time of implant.
7. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
8. 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).
9. Subject has had an MI or cerebral vascular accident (CVA) within 3 months.
10. Subject is currently participating in an investigational drug or device clinical trial.
11. Subject has a known allergy or intolerance to the device components.
12. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
13. 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.
14. 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.

Primary outcomes:
measure: Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
timeFrame: At 12-month post procedure
measure: Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
timeFrame: Within 12-months post treatment
Secondary outcomes:
measure: Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
timeFrame: At implant
measure: Percentage of Participants That Experienced Perioperative Mortality
timeFrame: Within 30 days post treatment
measure: Percentage of Participants That Experienced Paraplegia
timeFrame: Within 30 days post treatment
measure: Percentage of Participants That Experienced Paraparesis
timeFrame: Within 30 days post treatment
measure: Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
timeFrame: Within 30 days post treatment
measure: Percentage of Participants That Experienced One or More Major Adverse Events
timeFrame: Within 30 days post treatment
measure: Percentage of Participants That Experienced Aneurysm-related Mortality
timeFrame: Within 12 months post treatment
measure: Percentage of Participants That Experience Aneurysm Rupture
timeFrame: Within 12 months post treatment
measure: Percentage of Participants That Experienced Conversion to Open Surgical Repair
timeFrame: Within 12 months post treatment
measure: Percentage of Participants That Experienced Endoleak(s)
timeFrame: At 12 months
measure: Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
timeFrame: Between 30 days and 12 months
measure: Percentage of Participants That Experienced Stent Graft Migration
timeFrame: Within 12 months post treatment
measure: Percentage of Participants That Experience Loss of Stent Graft Patency
timeFrame: Within 12 months post treatment
measure: Percentage of Participants That Experienced One or More Major Adverse Events
timeFrame: Within 12 months post treatment
measure: Percentage of Participants That Died (All-cause Mortality)
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Aneurysm-related Mortality
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Aneurysm Ruptures
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Conversions to Open Surgical Repair
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Type I Endoleaks
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Type III Endoleaks
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Type IV Endoleaks
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Secondary Endovascular Procedures
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
timeFrame: 0 through 1825 days post treatment
measure: Percentage of Participants That Experienced Loss of Stent Graft Patency
timeFrame: 0 through 1825 days post treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California - Healthcare Consultation Center
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Union Memorial
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Plymouth
country: United States
facility: Minneapolis Vascular Physicians
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Morristown
country: United States
facility: Advance Vascular Associates (Morristown Memorial Hospital)
state: New Jersey
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Shadyside Hospital - University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital - Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: University of Pennsylvania
name: Ronald Fairman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conrad MF, Tuchek J, Freezor R, Bavaria J, White R, Fairman R. Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft. J Vasc Surg. 2017 Aug;66(2):335-342. doi: 10.1016/j.jvs.2016.12.136. Epub 2017 Mar 30.