A Non-Randomized Study Evaluating the Use of the ReFlow Medical Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal Peripheral ArTeries
Phase: NA
Conditions: Chronic Total Occlusion of Artery of the Extremities
Sponsor: ReFlow Medical, Inc.

Reflow Medical Wingman Catheter Wing-IT Clinical Trial
RFM-CTO-13001
NCT03403426
Document Date: 03-OCT-2018

Confidential 
Rev 3, 10/03/2018 
pg. 2
PROTOCOL SUMMARY 
Title: 
A Non-Randomized Study Evaluating the Use of the ReFlow Medical 
Wingman Catheter to Cross Chronic Total Occlusions in Infrainguinal 
Peripheral ArTeries (Wing-IT) 
Design: 
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.   
Purpose: 
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.  
Enrollment and 
Sites: 
A maximum of 85 patients will be enrolled and treated with the 
investigational device at up to twelve (12) centers in North America and 
three (3) centers in Europe.   
Time Course: 
Initial enrollment: Q1 2018 
Last enrollment:  Q1 2019 
Last follow-up:  Q1 2019 
Primary Efficacy and 
Safety Endpoints: 
Primary Efficacy: 
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. 
Primary Safety: 
No evidence of significant in-hospital or 30-day MAEs.  No evidence of 
clinically significant perforation, clinically significant embolization or ≥
Grade C dissection, after Wingman CTO crossing and prior to 
adjunctive interventions, confirmed by angiography. Components of the 
composite primary safety endpoint include:  
•
Major Adverse Events (MAEs) defined as death, unplanned
target limb major amputation, and emergent target vessel
revascularization.
•
Clinically significant perforation defined as all perforations
requiring intervention (e.g., covered stent, bypass or other
surgery) 1
•
Clinically significant embolization defined as those events that
result in distal ischemia (e.g., occlusion of run-off vessel

Confidential  
Rev 3, 10/03/2018 
 pg. 3 
 
resulting in pain or foot discoloration) and/or requires rescue 
intervention.  
• 
Grade C Dissection or greater with a minimum of a dissection 
protruding outside the lumen of the vessel persisting after 
passage of the contrast material.1 
 
The components of the primary and secondary safety endpoints will be 
adjudicated by an independent CEC with angiographic elements 
assessed by an independent core laboratory. 
 
 
Secondary 
Endpoints: 
1) Lesion success, defined as attainment of <50% final residual 
stenosis of the target lesion using any percutaneous method.   
2) 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.  
3) Procedure safety, defined as any in-hospital AE or MAE following 
use of a therapeutic interventional device.   
4) Evaluation of total procedural and fluoroscopic time and contrast 
volume. 
5) Evaluation of procedure time associated with use of the 
investigational device.  
6) Evaluation of utility of ancillary device in addition to investigational 
device. 
 
 
Inclusion Criteria: 
1) Patient is willing and able to provide informed consent. 
2) Patient is willing and able to comply with the study protocol. 
3) Patient is > 18 years old. 
4) Patient has peripheral arterial disease requiring revascularization as 
evidenced by contrast, CT or MR angiography. 
5) 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. 
6) Target lesion(s) is ≥ 1 cm and < 30 cm in length by visual estimate. 
7) Target vessel is ≥ 2.0 mm in diameter. 
8) Patient has Rutherford Classification of 2-5. 
9) Lesion cannot be crossed by concurrent conventional guidewire. 
10) Reconstitution of vessel at least 2cm above bifurcation/trifurcation. 
11) Occlusion can be within previously implanted stent. 
 
Exclusion Criteria: 
1) Patient has a known sensitivity or allergy to contrast materials that 
cannot be adequately pre-treated.  
2) Patient has a known sensitivity or allergy to all anti-platelet 
medications.  
3) Patient is pregnant or lactating.   
4) Patient has a co-existing disease or medical condition 
contraindicating percutaneous intervention.   
5) Target lesion is in a bypass graft. 

Confidential  
Rev 3, 10/03/2018 
 pg. 4 
 
6) Patient has had a failed crossing attempt without an intervening 
intervention on the target limb within the past 14 days.   
7) Patient has a planned surgical or interventional procedure within 30 
days after the study procedure. 
 
 
Data Analysis 
Center: 
Syntactx 
4 World Trade Center  
150 Greenwich Street / 44th Floor 
New York, NY 10007 
 
Sponsor: 
ReFlow Medical, Inc. 
1003 Calle Sombra,  
San Clemente, CA 92673 
Principal 
Investigator: 
 
Dr. John Laird 
 
Angiographic Core 
Lab 
Yale Cardiovascular Research Group 
135 College Street, Suite 101 
New Haven, CT 06510