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

Zhejiang University

Status: Invitation-only

Conditions: Peripheral Arterial Disease

Treatments: Device: Chocolate PTA Balloon Catheter

Study type: Observational

Funder types: Other

Identifiers

NCT06933992

NV-001-HZFH

Details and patient eligibility

About

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

Enrollment: 171 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

171 participants in 1 patient group

Chocolate PTA for PAD

Description:

This cohort comprises patients with symptomatic peripheral artery disease (Rutherford class 2-5) undergoing percutaneous transluminal angioplasty (PTA) using the Chocolate balloon catheter as part of routine care. Participants will be prospectively followed for 12 months to assess target lesion patency, revascularization rates, and clinical outcomes. Inclusion criteria: age ≥18 years, de novo/restenotic lesions (≤150 mm) in native lower limb arteries, and reference vessel diameter 4-6 mm.

Treatment:

Device: Chocolate PTA Balloon Catheter