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FAST II Clinical Trial

Evaluation of the FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST II)

Cardio Flow received an Investigational Device Exemption (IDE) approval for its FAST II clinical trial from the FDA in August 2018 and began enrolling patients later that year. The study originally involved the FreedomFlow® pneumatically powered system, but a new electric system was approved by the FDA in September 2020 for inclusion in the trial.

Cardio Flow completed enrollment in the FAST II trial in Q1 2021.

Study Objective: To evaluate the safety and effectiveness of the FreedomFlow® system for atherosclerotic plaque removal and vessel modification in de novo target lesions in the peripheral vasculature of the lower extremities.

Investigational Product: Cardio Flow FreedomFlow® Orbital Atherectomy System – Pneumatic

  • CM1001 – Control Module and Tubing Set
  • H3001 – User Handle 6 Fr
  • H4001 – User Handle 5 Fr

Investigational Product: Cardio Flow FreedomFlow® Orbital Atherectomy System – Electric

  • H6001 – User Handle 5 Fr
  • H6002 – User Handle 6 Fr
  • H7001 – Reusable Power Supply

Study Design: Prospective, multi-center, non-randomized single-arm study.

Enrollment Size and Number of Sites: Up to 112 participants at 15 locations in the United States, with approximately half treated with the pneumatic system and half treated with the electric system.

Primary Outcome Measures:

Primary safety endpoint is freedom from a composite of new onset major adverse events (MAE) at 30 day follow-up, as adjudicated by an Independent Clinical Events Committee.

Technical success, as defined as the ability of the Cardio Flow FreedomFlow® Orbital Circumferential Atherectomy System to achieve a residual diameter stenosis ≤ 50% without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory.

Study Duration: Enrollment began in December 2018 and was completed in Q1 2021.

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