ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries

To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.

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.