ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

Not Applicable

Completed

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Wingman Crossing Catheter	Wingman Crossing Catheter	Use of the device to support CTO crossing

Primary Outcome Measures

Name	Time	Method
Number of Lesions With Successful CTO Crossing Assessed by Angiography	Intraprocedural	While using the Wingman device, successful CTO crossing is identified by successful guidewire placement in the distal true lumen confirmed by angiography with no clinically significant perforations. Assessment by angiography with results reviewed by an independent core lab.
Major Adverse Event (MAE) Rate	Assessed from the time of the procedure through 30 days	Occurrence of significant in-hospital or 30-day MAEs.
Rate of Clinically Significant Perforations	Will be assessed from the time of the procedure through 30 days	Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab

Secondary Outcome Measures

Name	Time	Method
Incidence of In-hospital AE or MAE	Intraprocedural	Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device
Lesion Success	Intraprocedural	Lesion success, defined as attainment of \<50% final residual stenosis of the target lesion using any percutaneous method
Procedure Success Rate	Approximately 24 hours post procedure	Procedure success, defined as device success and the absence of in-hospital MAEs, clinically significant perforation, clinically significant embolization or Grade C or greater dissection not resolved by visual estimate
Total Procedural Time	Approximately 24 hours post procedure	Evaluation of total procedural time
Device Procedural Time	Approximately 24 hours post procedure	Evaluation of procedure time associated with use of the investigational device.
Contrast Use	Approximately 24 hours post procedure	Evaluation of total procedural contrast volume use
Fluoroscopic Time	Approximately 24 hours post procedure	Evaluation of total procedural fluoroscopic time