Evaluation of the FreedomFlow™ Orbital Atherectomy System to Treat Peripheral Artery Disease

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.

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 (PAD) 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.

Eligibility Criteria:
Subjects must meet all of the following criteria to be eligible for participation in the study:

Inclusion Criteria

1. Age ≥ 18 years old.
2. Subject is a candidate for percutaneous endovascular intervention for peripheral vascular disease in the lower extremity.
3. Objective hemodynamic criteria that subject has a resting ankle-brachial index (ABI) ≤ 0.90 OR a resting toe-brachial index (TBI) of ≤ 0.80 OR ankle pressure of ≤70 mmHg.
4. Clinical presentation of lifestyle limiting claudication, rest pain and/or ischemic wounds as characterized by Rutherford Classification 2, 3, 4, or 5.
5. Disease is located in the common femoral, superficial femoral, popliteal, tibioperoneal, anterior tibial, posterior tibial, and/or peroneal arteries.

   1. De novo target lesion(s) with stenosis ≥70% by visual estimation and/or
   2. Lesion(s) treated by percutaneous transluminal angioplasty (PTA) and/or atherectomy ≥3 months prior with a restenosis ≥70% by visual estimation.
   3. Up to three lesions can be treated at the index procedure provided the cumulative total lesion length is ≤ 20 cm AND all lesions are in the same target leg.
6. Target reference vessel diameter (proximal to and distal to target lesion) is 2 to 8 mm by angiographic visual estimation.
7. At least one patent vessel run-off to the ankle or foot at baseline.
8. The target lesion(s) can be successfully crossed with a commercially available 0.014" atherectomy guidewire without any complications during wiring procedure.
9. Subject signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure.

Subject must be excluded from participation in this study if any of the following criteria are met:

Exclusion Criteria

1. Is female with childbearing potential not taking adequate contraceptives or is currently breastfeeding.
2. Target lesion is within a native graft or synthetic graft.
3. Target lesion is an in-stent restenosis.
4. Target lesion is a chronic total occlusion (CTO) with occlusion length greater than 10 cm and/or with wire crossed sub-intimally. CTO wire placement in true lumen must be confirmed via Intra-vascular ultrasound (IVUS) prior to enrollment.
5. Subject has significant stenosis or occlusion of inflow tract (upstream disease) not successfully treated during the index procedure and prior to treatment of the target lesion.
6. Intra-operative (intra-procedure) clinical or angiographic complication (other than non-flow limiting dissections) attributed to the use of a currently marketed device prior to introduction of the Cardio Flow atherectomy drive shaft.
7. Evidence or history of aneurysmal target vessel.
8. Clinical/angiographic evidence of distal embolization prior to intervention.
9. History of an endovascular procedure or open vascular surgery on the index limb within 30 days prior to the index procedure. Endovascular procedure or open vascular surgery on the non-index limb cannot be staged within 2 weeks prior to the index procedure.
10. Planned endovascular or surgical procedure prior to the subject's 30 day follow up.
11. Signs and symptoms of systemic infection (temperature of ≥ 38.0° Celsius and/or white blood cell count (WBC) of ≥ 12,000 cells/µL) at the time of assessment; Note: If infection is adequately treated and controlled (temperature \< 38.0° C and WBC \< 12,000 cells/µL) patient may be enrolled.
12. Unstable coronary artery disease or other comorbid condition(s) that, in the judgment of the physician precludes safe percutaneous intervention.
13. Significant acute or chronic kidney disease with a creatinine level \> 2.5mg/dL and/or requiring dialysis.
14. Evidence of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stoke within 2 months of index procedure.
15. Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
16. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
17. Heparin-induced thrombocytopenia (HIT) not able to use Bivalirudin.
18. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2, known coagulopathy, or international normalized ratio (INR) \> 1.8.
19. Evidence of thrombus within target lesion or thrombolytic therapy within 2 weeks of the index procedure.
20. Has life expectancy \< 12 months in the opinion of the investigator.
21. Subject is unwilling or unable to comply with the follow-up study requirements.
22. Subject is currently participating in an investigational drug or another investigational device exemption (IDE) study.