N/A Completed N=85 Treatment

ReFlow Medical Wingman Catheter Wing-IT Clinical Trial

Chronic Total Occlusion of Artery of the Extremities

Source: ClinicalTrials.gov NCT03403426 ↗

Enrolled (actual)

Serious AEs

25.9%

Results posted

Jan 2021

Primary outcomePrimary: Number of Lesions With Successful CTO Crossing Assessed by Angiography — 77 lesions

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Lesions With Successful CTO Crossing Assessed by Angiography	77	—
PRIMARY Major Adverse Event (MAE) Rate	4	—
PRIMARY Rate of Clinically Significant Perforations	1	—
SECONDARY Lesion Success	77	—
SECONDARY Procedure Success Rate	75	—
SECONDARY Incidence of In-hospital AE or MAE	16	—
SECONDARY Total Procedural Time	102	—
SECONDARY Device Procedural Time	12	—
SECONDARY Contrast Use	148	—
SECONDARY Fluoroscopic Time	30	—

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03403426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.