Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)

Exclusion Criteria

• •Active systemic infection or uncontrolled coagulation disorder within 14 days prior to procedure.
• •Planned major amputation of the target limb (at or above the ankle).
• •Renal insufficiency (MDRD eGFR ≤30 mL/min/1.73 m²) or serum creatinine ≥2.5 mg/dL within 30 days, or dialysis dependence.
• •Contraindication to antiplatelet therapy (aspirin/clopidogrel), low-molecular-weight heparin, vasodilators, or contrast agents.
• •Uncontrolled systemic comorbidities (e.g., severe cardiac/pulmonary/hepatic dysfunction, advanced malignancy, uncorrected coagulopathy).
• •History of cerebral hemorrhage, symptomatic stroke, myocardial infarction, or gastrointestinal bleeding within 6 months.
• •Pregnancy, lactation, or planned pregnancy (men or women).
• •Participation in another interventional clinical trial with unmet primary endpoint.
• •Investigator-determined medical, social, or psychological contraindications.
• •Life expectancy \<1 year.