CompletedNot Applicable

Valor II: The Valiant Thoracic Stent Graft System Clinical Study

United States160 participantsStarted 2006-12

Plain-language summary

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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion 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;
. 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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)

Timeframe: 0 through 1825 days post treatment

Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)

Timeframe: At 12-month post procedure

Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >

Timeframe: Within 12-months post treatment

Trial details

NCT IDNCT00413231

SponsorMedtronic Cardiovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-08

Results submitted2011-12-23

View on ClinicalTrials.gov More Thoracic Aortic Aneurysm trials