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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thoracic Aortic Aneurysm
- Sponsor
- Medtronic Cardiovascular
- Enrollment
- 160
- Locations
- 26
- Primary Endpoint
- Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Time Frame: 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)
Time Frame: 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) > >
Time Frame: 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. \> \> 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 Outcomes
- Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant(At implant)
- Percentage of Participants That Experienced Perioperative Mortality(Within 30 days post treatment)
- Percentage of Participants That Experienced Aneurysm-related Mortality(0 through 1825 days post treatment)
- Percentage of Participants 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 Participants That Experienced Type III Endoleaks(0 through 1825 days post treatment)
- Percentage of Participants That Experienced Type IV Endoleaks(0 through 1825 days post treatment)
- Percentage of Participants That Experienced Paraplegia(Within 30 days post treatment)
- Percentage of Participants 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 Participants That Experienced Conversions to Open Surgical Repair(0 through 1825 days post treatment)
- Percentage of Participants 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 Participants That Experienced Stent Graft Migration(Within 12 months post treatment)
- Percentage of Participants 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 Participants That Died (All-cause Mortality)(0 through 1825 days post treatment)
- Percentage of Participants That Experienced Aneurysm Ruptures(0 through 1825 days post treatment)
- Percentage of Participants That Experienced Type I Endoleaks(0 through 1825 days post treatment)
- Percentage of Participants That Experienced Secondary Endovascular Procedures(0 through 1825 days post treatment)
- Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)(0 through 1825 days post treatment)
- Percentage of Participants That Experienced Loss of Stent Graft Patency(0 through 1825 days post treatment)