N/A
N=85
ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
Chronic Total Occlusion of Artery of the Extremities
Bottom Line
View on ClinicalTrials.gov: NCT03403426 ↗Enrolled (actual)
85
Serious AEs
25.9%
Results posted
Jan 2021
Primary outcome: Primary: Number of Lesions With Successful CTO Crossing Assessed by Angiography — 77 lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wingman Crossing Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ReFlow Medical, Inc.
- Primary completion
- Aug 2019
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 | — |
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.
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.
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.