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

Evaluation of the Safety and Efficacy of the Chocolate Balloon Catheter in Percutaneous Transluminal Angioplasty (PTA) for Peripheral Arterial Disease (PAD): A Prospective, Multicenter, Single-Arm Observational Trial

This study aims to learn about the long-term safety and effectiveness of the Chocolate Balloon Catheter in patients with blocked leg arteries (peripheral artery disease, or PAD). The Chocolate Balloon is a special type of balloon used during minimally invasive procedures to open narrowed arteries while potentially causing less damage to the blood vessel.

The main question it aims to answer is:

Does the Chocolate Balloon keep the treated artery open after 12 months without needing repeat procedures? Patients with PAD who are already scheduled to undergo an artery-opening procedure (angioplasty) with the Chocolate Balloon as part of their standard care will answer the question about the safety and effectiveness of the Chocolate Balloon Catheter

Inclusion Criteria:

• Participant or legal guardian provides written informed consent.
• Age ≥18 and ≤80 years, regardless of gender.
• De novo target lesion located in the native superficial femoral, popliteal, or infrapopliteal artery.
• Life expectancy >1 year as assessed by the investigator.
• Candidate suitable for endovascular angiography and intervention per investigator judgment.
• Willingness to undergo Chocolate Balloon Catheter PTA.

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.