Clinical Trials

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.

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.

Feasibility Clinical Trial of the Cardio Flow FreedomFlow Orbital Atherectomy System to Treat Peripheral Artery Disease (FAST Trial)

Cardio Flow received an Investigational Device Exemption (IDE) approval for its FreedomFlow® Orbital Atherectomy System First-in-Human (FIH) clinical trial from the FDA in November 2017.

Cardio Flow began enrolling patients for this study in January 2018 and completed the study in November 2018.

Investigational Product: Cardio Flow FreedomFlow® Orbital Atherectomy System

• CM1001 – Control Module and Tubing Set
• H4001 – User Handle

Study Design: Prospective, 2 centers, non-randomized single-arm study

Enrollment Size and Number of Sites: Up to 10 subjects at up to 2 sites in the United States.

Primary Effectiveness: Technical success, defined as the ability of the Cardio Flow FreedomFlow® Orbital Atherectomy System to achieve a residual diameter stenosis ≤50% post treatment with or without adjunctive therapy, as assessed by an independent Angiographic Core Laboratory

Study Duration: Enrollment time was approximately 2 months, with observation periods at time of procedure, pre-discharge, 30 days, and 6 months post-procedure follow-up.