Evaluation of the FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease
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- STATUS
- Recruiting
-
- participants needed
- 112
-
- sponsor
- Cardio Flow, Inc.
Holly Cabagay, RTR, RCIS
Primary Contact
Eastlake Cardiovascular, PC (2.9 mi away) Contact
+14 other locationSummary
To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.
Description
The FAST II study is a prospective, multi-center, non-randomized single-arm trial designed to evaluate the safety and effectiveness of the FreedomFlow Orbital Circumferential Atherectomy System in subjects diagnosed with peripheral arterial disease of the lower extremities.
The FreedomFlow Orbital Circumferential Atherectomy System is a minimally invasive, catheter-based system designed for improving luminal diameter and modifying vessel wall compliance in patients with PAD.
The FreedomFlow Orbital Circumferential Atherectomy System is indicated to remove atherosclerotic plaque and modifying vessel wall compliance within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.
The objective of the study is to evaluate the safety and effectiveness of the FreedomFlow Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel modification in de novo target lesions in the peripheral vasculature of the lower extremities.
Details
| Condition | Peripheral vascular disease, Circulation Disorders, Peripheral vascular disease, peripheral arterial disease, Peripheral Arterial Disease (PAD), Circulation Disorders, Peripheral Arterial Disease (PAD), peripheral arterial diseases, peripheral artery disease |
|---|---|
| Treatment | Orbital Circumferential Atherectomy |
| Clinical Study Identifier | NCT03635190 |
| Sponsor | Cardio Flow, Inc. |
| Last Modified on | 16 August 2022 |
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