Valiant Evo US Clinical Trial
(VEVO Trial)

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen byAli Azizzadeh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic Cardiovascular

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for endovascular repair.

Research Team

Ali Azizzadeh, MD

Principal Investigator

Cedars-Sinai Heart Institute

Eligibility Criteria

Inclusion Criteria

Subject understands and voluntarily has signed and dated the Informed Consent Form approved by the Sponsor and by the Ethics Committee for this study.

Subject presents a Descending Thoracic Aortic Aneurysm (DTAA) which is localized below the ostium of Left Subclavian Artery (LSA) and above the ostium of celiac trunk

Subject has a DTAA that is one of the following: A fusiform aneurysm with a maximum diameter that: is ≥ 50 mm and/or: is > 2 times the diameter of the non-aneurysmal thoracic aorta and/or: is < 50 mm and has grown ≥ 5 mm within previous 12 months; A saccular aneurysm or a penetrating atherosclerotic ulcer

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Exclusion Criteria

Subject is participating in another investigational drug or device study which would interfere with the endpoints and follow-ups of this study.

Subject is pregnant.

Subject requires planned placement of the covered proximal end of the stent graft to occur in zones 0 or 1.

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