Clinical trial NCT06933992: Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Peripheral Arterial Disease
Keywords: Chocolate Balloon Catheter
Percutaneous Transluminal Angioplasty
Peripheral Arterial Disease
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be selected from patients diagnosed with symptomatic peripheral artery disease (Rutherford class 2-5) who are undergoing percutaneous transluminal angioplasty (PTA) with the Chocolate balloon catheter as part of standard care. The ages of participants range from 18 to 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 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


Eligibility criteria: 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.

Primary outcomes:
measure: Target lesion patency rate at 12 months post-procedure
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Rate of Acute Angiographic Success Defined as Core Lab-Assessed Residual Stenosis ≤30% Without Flow-Limiting Dissection (Grade D or Higher)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Rate of bailout stenting
timeFrame: From enrollment to the end of treatment at 12 months
measure: Number of Participants with Improvement in Rutherford Clinical Category from Baseline
timeFrame: From enrollment to the end of treatment at 12 months
measure: Freedom from clinically driven Target Lesion Revascularization (TLR) at 1, 6, and 12 months
timeFrame: From enrollment to the end of treatment at 12 months
measure: Change in Ankle-Brachial Index (ABI) from Baseline
timeFrame: From enrollment to the end of treatment at 12 months
measure: Change in Toe-Brachial Index (TBI) from Baseline
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
Study officials:
affiliation: First People's Hospital of Hangzhou
name: Meng Xiaohu, MS
role: PRINCIPAL_INVESTIGATOR
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