Feasibility Clinical Trial of the Cardio Flow Orbital Atherectomy System to Treat PAD

Feasibility Clinical Trial of the Cardio Flow FreedomFlow™ Orbital Atherectomy System to
Treat Peripheral Artery Disease (FAST Trial) is a prospective non-randomized single arm study
that will enroll up to 10 patients at 1 - 2 sites. The study will evaluate the safety and
effectiveness of the Cardio Flow atherectomy device for plaque removal in de novo target
lesions in the peripheral vasculature of the lower extremities. The primary safety endpoint
is defined as freedom from a composite of new onset major adverse events through the 30-day
follow-up as adjudicated by an independent Clinical Events physician. The primary
effectiveness endpoint is defined as the ability of the Cardio Flow Device to achieve a
residual diameter stenosis ≤ 50% without adjunctive therapy, determined by Angiographic core
lab evaluation.

Inclusion Criteria:

- Candidate for percutaneous endovascular intervention in the lower extremity; disease
is located in peripheral arteries between 2mm and 5mm diameter; ankle brachial index ≤
0.90; Rutherford classification 2,3,4 or 5; de novo target lesion has ≥ 50% stenosis;
target lesion length ≤ 200 cm; at least 1 patent tibial vessel runoff; written, signed
informed consent.

Exclusion Criteria:

- Female not using adequate contraception or is breastfeeding; Rutherford class 0 1, and
6; target lesion within a native graft, in-stent restenosis, ≤ 50% occlusion, or
chronic total occlusion; history of vascular surgery or interventional procedure on
index limb within 30 days prior to procedure, or planned procedure within 30 days
after index procedure, lesion in contralateral limb requiring intervention during
index procedure or within 30 days of index procedure; known or suspected systemic
infection; unstable coronary disease; significant kidney disease requiring dialysis;
evidence of aneurysmal target vessel within past 2 months; evidence of intracranial or
GI bleeding, intracranial aneurysm, MI or stroke within 2 months of baseline
evaluation; history of heparin-induced thrombocytopenia; contraindication to
anti-platelet, anticoagulant, or thrombolytic therapy; uncorrected bleeding disorders;
thrombolytic therapy within 2 weeks of index procedure; life expectancy less than 12
months; unwilling or unable to comply with follow-up requirements; intraoperative
complications due to the use of a marketed device prior to use of the atherectomy
system; currently participating in an investigational drug or other device study that
has not completed primary endpoint; unable to tolerate standard interventional
procedures if the study device is not effective.