At a glance
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Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease
In Brief
A clinical study evaluating Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment and Balloon Angioplasty for Peripheral Arterial Disease. Completed, enrolled 10 participants across 2 sites.
Detailed Summary
This trial is a First in Human early feasibility study of a novel atherectomy device to treat peripheral artery disease. The trial is a prospective, single arm design that will enroll 10 patients at 1 - 2 sites. Patients will be followed at 30 days and 6 months to evaluate vessel patency following treatment. Safety will be assessed by monitoring adverse events throughout the study. Safety and Efficacy will be evaluated by comparing study results to established performance criteria,
Study Details
Timeline
Interventions
Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.
Low pressure balloon angioplasty may be used following atherectomy