At a glance
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Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization
In Brief
A clinical study evaluating Revolution™ Peripheral Atherectomy System for Peripheral Artery Disease. Completed, enrolled 121 participants across 17 sites.
Detailed Summary
To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease. This Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and the presence of any major adverse events (safety) for up to 30 days after the procedure.
Study Details
Timeline
Interventions
The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.