Clinical Research Directory

Inclusion Criteria: 1. Rutherford classification category ≥4; 2. Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System; 3. Calcification of target lesions must be visible on fluoroscopy or CT-angiography; 4. Patients competent and willing to provide informed consent. Exclusion Criteria: 1. Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.); 2. Inadequate inflow (\>30% stenosis) following optimization; 3. Insufficient direct outflow (less than 1 run-off vessel); 4. Endovascular procedure(s) on the treatment site within 4 weeks before index procedure; 5. Patients planned to receive an above ankle amputation of the target limb; 6. Patients enrolled in RESCUE (ClinicalTrials.gov ID NCT07270575).