Table 1.

DEFINITIVE Ca⁺⁺ Inclusion and Exclusion Criteria

Inclusion criteria	Exclusion criteria
• Has a RCC Score of 2, 3 or 4.	• •Has known hypersensitivity to nitinol.
• Is willing to comply with all follow-up evaluations at the specified times.	• Has known hypercoagulable condition, or refuses blood transfusion.
• Is ≥ 18 years old.	• Is female with childbearing potential not taking adequate contraceptives or is currently breastfeeding.
• Provides written informed consent prior to any study-related procedures and enrollment in the study.	• Has life expectancy of <12 months.
• Has target lesion(s) located within the native femoropopliteal artery with target vessel diameter ≥3.5 mm and ≤7.0 mm, with the proximal point of the target lesion at least one cm below the origin of the profunda femoralis.	• Has any planned surgical intervention or endovascular procedure 30 days after the index procedure.
• Target lesion(s) has moderate to severe calcification visualized on angiogram.	• Has surgical or endovascular procedure of the target vessel within 30 days prior to the index procedure.
• Has evidence of ≥75% stenosis in the target lesion(s) confirmed by angiography.	• Is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
• The target lesion(s) total length is ≤15 cm and any individual target lesion is ≤10 cm as determined by a spatially calibrated measurement using a device with known distance between radiopaque markers	• The guidewire cannot cross the target lesion and/or a subintimal approach is required.
• There is at least one target lesion identified to be treated.	• Has significant stenosis or occlusion of inflow tract not successfully treated before the treatment of the target lesion.
• There is evidence of at least single vessel runoff to the ankle/foot of the limb to be treated that does not also require treatment for significant (>50% stenosis or occlusion) stenosis during the index procedure. Treatment of infrapopliteal lesions must be staged at least 30 days before or after the index procedure.	• There is presence of an aneurysm in a target vessel.
• There is evidence that a SpiderFX can be placed in a vessel 3–6 mm in diameter and at least eight cm beyond the distal edge of the target lesion.	• There is presence of an acute intraluminal thrombus at the proposed lesion site.
	• One or more of the following occurred prior to enrollment: clinical perforation, dissection (grade C or greater), pseudo-aneurysm, thrombosis, distal embolism, or other injury requiring additional stenting or surgical intervention prior to crossing the first target lesion.
	• The target lesion is an in-stent restenosis.
	• There is known or suspected active systemic infection.
	• The subject has other comorbid condition(s) that, in the judgment of the physician preclude(s) safe percutaneous intervention.
	• A lesion in the nontarget limb is treated on the same day as the target limb.