Status:
COMPLETED
ReFlow Medical Wingman Catheter Wing-IT Clinical Trial
Lead Sponsor:
ReFlow Medical, Inc.
Conditions:
Chronic Total Occlusion of Artery of the Extremities
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2019
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT03403426
Start Date
February 13 2018
End Date
August 8 2019
Last Update
January 7 2021
Active Locations (1)
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1
Adventist St. Helena Hospital
St. Helena, California, United States, 94574