Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)
Key facts
- Where
- Hangzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06933992, who can take part
Where in China
- Hangzhou First People's HospitalHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- First People's Hospital of Hangzhou
- Trial code
- NCT06933992
- Record updated
- 18 April 2025
- Original description
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.Read full original descriptionShow less
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: 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; 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; Renal insufficiency (MDRD eGFR ≤30 mL/min/1.73 m²) or serum creatinine ≥2.5 mg/dL within 30 days, or dialysis dependence; Planned major amputation of the target limb (at or above the ankle); 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.