ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

Prospective, multi-center, non-randomized single-arm study of the Wingman Catheter to cross a single infrainguinal peripheral chronic total occlusion (CTO). Safety and effectiveness will be evaluated during the index procedure through 30-day follow-up.

Inclusion criteria

• Patient is willing and able to provide informed consent.
• Patient is willing and able to comply with the study protocol.
• Patient is > 18 years old.
• Patient has peripheral arterial disease requiring revascularization as evidenced by contrast, CT or MR angiography.
• Patient has at least one but not more than two occluded infrainguinal arteries that are 99-100% stenosed and no flow is observed in the distal lesion except the flow from collateral circulation.
• Target lesion(s) is ≥ 1 cm and < 30 cm in length by visual estimate.
• Target vessel is ≥ 2.0 mm in diameter.
• Patient has Rutherford Classification of 2-5.
• Lesion cannot be crossed by concurrent conventional guidewire.
• Reconstitution of vessel at least 2cm above bifurcation/trifurcation.
• Occlusion can be within previously implanted stent.

Exclusion criteria

• Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
• Patient has a known sensitivity or allergy to all anti-platelet medications.
• Patient is pregnant or lactating.
• Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
• Target lesion is in a bypass graft.
• Patient has had a failed crossing attempt without an intervening intervention on the target limb within the past 14 days.
• Patient has a planned surgical or interventional procedure within 30 days after the study procedure.