Status:
ENROLLING_BY_INVITATION
Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)
Lead Sponsor:
First People's Hospital of Hangzhou
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-80 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT06933992
Start Date
July 20 2025
End Date
December 20 2027
Last Update
April 18 2025
Active Locations (1)
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1
Hangzhou First People's Hospital
Hangzhou, China