Valor II: The Valiant Thoracic Stent Graft System Clinical Study
- Conditions
- Thoracic Aortic Aneurysm
- Interventions
- Device: Valiant Thoracic Stent Graft System
- Registration Number
- NCT00413231
- Lead Sponsor
- Medtronic Cardiovascular
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Valiant Thoracic Stent Graft System Valiant Thoracic Stent Graft System 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) 0 through 1825 days post treatment 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.
Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint) At 12-month post procedure 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).Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > > Within 12-months post treatment 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.
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\> 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.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant 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.
Percentage of Participants That Experienced Perioperative Mortality Within 30 days post treatment Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.
Percentage of Participants That Experienced Aneurysm-related Mortality 0 through 1825 days post treatment Percentage of subjects that experienced aneurysm-related within five years post implant
Percentage of Participants That Experience Aneurysm Rupture Within 12 months post treatment Percentage of subjects that experience aneurysm rupture within 12 months post treatment
Percentage of Participants That Experience Loss of Stent Graft Patency Within 12 months post treatment Percentage of subjects that experience loss of stent graft patency within 12 months post treatment
Percentage of Participants That Experienced Type III Endoleaks 0 through 1825 days post treatment Percentage of subjects that experienced type III endoleaks within five years post implant
Percentage of Participants That Experienced Type IV Endoleaks 0 through 1825 days post treatment Percentage of subjects that experienced type IV endoleaks within five years post implant
Percentage of Participants That Experienced Paraplegia Within 30 days post treatment Percentage of subjects that experienced paraplegia within 30 days post treatment
Percentage of Participants That Experienced Paraparesis Within 30 days post treatment Percentage of subjects that experienced paraparesis within 30 days post treatment
Percentage of Participants That Experienced One or More Major Adverse Events Within 12 months post treatment Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment
Percentage of Participants That Experienced Conversions to Open Surgical Repair 0 through 1825 days post treatment Percentage of subjects that experienced conversions to open surgical repair within five years post implant
Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge Within 30 days post treatment Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment
Percentage of Participants That Experienced Endoleak(s) At 12 months Percentage of subjects that experienced endoleak(s) of any type at 12 months
Percentage of Participants That Experienced Stent Graft Migration Within 12 months post treatment 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.
Percentage of Participants That Experienced Conversion to Open Surgical Repair Within 12 months post treatment Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment
Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak Between 30 days and 12 months Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months
Percentage of Participants That Died (All-cause Mortality) 0 through 1825 days post treatment 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
Percentage of Participants That Experienced Aneurysm Ruptures 0 through 1825 days post treatment Percentage of subjects that experienced aneurysm ruptures within five years post implant
Percentage of Participants That Experienced Type I Endoleaks 0 through 1825 days post treatment Percentage of subjects that experienced type I endoleaks within five years post implant
Percentage of Participants That Experienced Secondary Endovascular Procedures 0 through 1825 days post treatment Percentage of subjects that experienced secondary endovascular procedures within five years post implant
Percentage of Participants That Experienced Stent Graft Migrations (Site Reported) 0 through 1825 days post treatment Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites
Percentage of Participants That Experienced Loss of Stent Graft Patency 0 through 1825 days post treatment Percentage of subjects that experienced loss of stent graft patency within five years post implant
Trial Locations
- Locations (26)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Southern California - Healthcare Consultation Center
🇺🇸Los Angeles, California, United States
Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Union Memorial
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Scroll for more (16 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States