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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Total Occlusion of Artery of the Extremities
• Intervention / Treatment: Device: Wingman Crossing Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Saint Helena, California, United States, 94574
      • Adventist St. Helena Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wingman Crossing Catheter; Use of the device to support CTO crossing	Device: Wingman Crossing Catheter; Endovascular CTO crossing

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ReFlow Medical, Inc.
• Investigators: Principal Investigator: John Laird, MD, Adventist St. Helena Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Actual): August 8, 2019
• Study Completion (Actual): August 8, 2019

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: RFM-CTO-13001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes