ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Total Occlusion of Artery of the Extremities

Intervention / Treatment
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* Device: Wingman Crossing Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wingman Crossing Catheter<br>Use of the device to support CTO crossing | Device: Wingman Crossing Catheter<br>* Endovascular CTO crossing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Lesions With Successful CTO Crossing Assessed by Angiography | 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. | Intraprocedural | 
| Major Adverse Event (MAE) Rate | Occurrence of significant in-hospital or 30-day MAEs. | Assessed from the time of the procedure through 30 days | 
| Rate of Clinically Significant Perforations | Occurrence of clinically significant perforation, after Wingman CTO crossing and PTA of lesion, confirmed by angiography, evaluated by angiographic core lab | Will be assessed from the time of the procedure through 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Success | Lesion success, defined as attainment of <50% final residual stenosis of the target lesion using any percutaneous method | Intraprocedural | 
| Procedure Success Rate | 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 | Approximately 24 hours post procedure | 
| Incidence of In-hospital AE or MAE | Procedure safety defined as any in-hospital AE or MAE following use of a therapeutic interventional device | Intraprocedural | 
| Total Procedural Time | Evaluation of total procedural time | Approximately 24 hours post procedure | 
| Device Procedural Time | Evaluation of procedure time associated with use of the investigational device. | Approximately 24 hours post procedure | 
| Contrast Use | Evaluation of total procedural contrast volume use | Approximately 24 hours post procedure | 
| Fluoroscopic Time | Evaluation of total procedural fluoroscopic time | Approximately 24 hours post procedure |