Objective performance goal efficacy and safety targets
Objective performance goal efficacy and safety targets
Efficacy: Freedom from CDTLR at 12 months Safety: Composite of MAE at 30 days
Secondary endpoints
Primary patency CDTLR Changes in Rutherford classification Changes in ABI measurements
Primary patency CDTLR Changes in Rutherford classification Changes in ABI measurements Changes in walking impairment questionnaire
Primary patency Changes in Rutherford classification Changes in ABI measurements
Subgroup analyses
Post hoc geometric analyses Presence and quantification of stented segment curvature based on geometric analysis of extended-leg and bent-knee X-ray measurements Presence and quantification of shear stress based on computational fluid dynamic modeling of duplex ultrasound data and bent-knee X-ray measurements
Presence and quantification of shear stress based on computational fluid dynamic modeling of duplex ultrasound data and bent-knee X-ray measurements
Adjunctive stenting with DCBs () Popliteal lesions Calcified lesions
Inclusion criteria
Patients with Rutherford category 1 to 4 with symptoms considered due to SFA disease Lesion length: 4 cm to 10 cm, capable of being treated by a single stent
Patients with Rutherford category 2 to 4 due to PAD Lesion length: 4 cm to 14 cm capable of being treated by a single stent or by multiple stents
Patients with documented PAD who receive the helical centerline stent in accordance with the IFU
Exclusion criteria
Previous interventions at target site within 6 months Previous stent placement in target limb
Target lesion(s) requires percutaneous interventional treatment, beyond standard balloon angioplasty alone, prior to placement of the study stent
Patients whose lesions that cannot be crossed with a wire and/or balloon catheter and cannot be dilated sufficiently to allow passage of the delivery system
