ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

NCT03403426 | Completed Results FDA Device

• 1 other identifier: RFM-CTO-13001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Total Occlusion of Artery of the Extremities

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Lesion Success

  Intraprocedural

• Procedure Success Rate

  Approximately 24 hours post procedure

• Incidence of In-hospital AE or MAE

  Intraprocedural

• Total Procedural Time

  Approximately 24 hours post procedure

• Device Procedural Time

  Approximately 24 hours post procedure

Study Arms (1)

Wingman Crossing Catheter

EXPERIMENTAL

Use of the device to support CTO crossing

Device: Wingman Crossing Catheter

Interventions

Wingman Crossing Catheter DEVICE

Endovascular CTO crossing

Wingman Crossing Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ReFlow Medical, Inc.: lead

Study Sites (1)

Adventist St. Helena Hospital

St. Helena, California, 94574, United States

Location

Results Point of Contact

• Title: Isa Rizk
• Organization: Reflow Medical

info@reflowmedical.com

9494810399

Study Officials

• John Laird, MD

  Adventist St. Helena Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: January 18, 2018
• Study Start: February 13, 2018
• Primary Completion: August 8, 2019
• Study Completion: August 8, 2019
• Last Updated: January 7, 2021
• Results First Posted: January 7, 2021

Record last verified: 2021-01

Locations

US (1)