ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

Chronic Total Occlusion of Artery of the Extremities Clinical Trial

— Wing-It  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403426
• Other study ID #: RFM-CTO-13001
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: August 8, 2019

Study information

• Verified date: January 2021
• Source: ReFlow Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Chronic Total Occlusion of Artery of the Extremities

Intervention

Device:
• Wingman Crossing Catheter
Endovascular CTO crossing

Locations

Country	Name	City	State
United States	Adventist St. Helena Hospital	Saint Helena	California

Sponsors (1)

Lead Sponsor	Collaborator
ReFlow Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Major Adverse Event (MAE) Rate	Occurrence of significant in-hospital or 30-day MAEs.	Assessed from the time of the procedure through 30 days
Primary	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	Lesion Success	Lesion success, defined as attainment of <50% final residual stenosis of the target lesion using any percutaneous method	Intraprocedural
Secondary	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
Secondary	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
Secondary	Total Procedural Time	Evaluation of total procedural time	Approximately 24 hours post procedure
Secondary	Device Procedural Time	Evaluation of procedure time associated with use of the investigational device.	Approximately 24 hours post procedure
Secondary	Contrast Use	Evaluation of total procedural contrast volume use	Approximately 24 hours post procedure
Secondary	Fluoroscopic Time	Evaluation of total procedural fluoroscopic time	Approximately 24 hours post procedure