ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
Completed · Not applicable
Conditions studied: Chronic Total Occlusion of Artery of the Extremities
In brief
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.
Key facts
- Study ID
- NCT03403426
- Run by
- ReFlow Medical, Inc.
- People needed
- 85
- Starts
- 2018-02-13
- Expected to finish
- 2019-08-08
- Last updated by the study team
- 2021-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Adventist St. Helena Hospital — St. Helena, California, United States
Full record on ClinicalTrials.gov
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