ReFlow Medical Wingman Catheter Wing-IT Clinical Trial (Wing-It)

Reflow Medical

Status

Completed

Conditions

Chronic Total Occlusion of Artery of the Extremities

Treatments

Device: Wingman Crossing Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT03403426

RFM-CTO-13001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.