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Enrolling by Invitation

NCT Number: NCT06933992

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

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

Enrolling by Invitation

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hangzhou First People's Hospital

Hangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chocolate PTA Balloon Catheter

Device

The Chocolate PTA balloon catheter is a nitinol-constrained percutaneous transluminal angioplasty balloon designed to minimize vessel trauma during treatment of peripheral arterial lesions. The device is used according to its standard indications and instructions for use in patients with symptomatic peripheral artery disease.

Primary outcomes

  1. Target lesion patency rate at 12 months post-procedure

    Time frame: From enrollment to the end of treatment at 12 months

    It is defined as the absence of restenosis (based on duplex Doppler ultrasound criteria: diameter stenosis >50% and peak systolic velocity ratio <2.5) and freedom from target lesion revascularization (TLR).

Secondary outcomes

  1. Rate of Acute Angiographic Success Defined as Core Lab-Assessed Residual Stenosis ≤30% Without Flow-Limiting Dissection (Grade D or Higher)

    Time frame: From enrollment to the end of treatment at 12 months

    Proportion of participants achieving successful revascularization, defined by two co-primary angiographic criteria: 1) Core laboratory-adjudicated residual stenosis ≤30%, and 2) Absence of flow-limiting dissection (Grade D or higher per NHLBI classification), assessed immediately after device deployment.

  2. Rate of bailout stenting

    Time frame: From enrollment to the end of treatment at 12 months

    The proportion of cases requiring emergency stent placement due to suboptimal Chocolate balloon angioplasty results (e.g., severe dissection, recoil, or residual stenosis).

  3. Number of Participants with Improvement in Rutherford Clinical Category from Baseline

    Time frame: From enrollment to the end of treatment at 12 months

    Proportion of participants achieving ≥1 category reduction in Rutherford Clinical Classification (Scale Range: 0 [asymptomatic] to 6 [major tissue loss]) at 12 months post-procedure, as assessed by blinded core lab

  4. Freedom from clinically driven Target Lesion Revascularization (TLR) at 1, 6, and 12 months

    Time frame: From enrollment to the end of treatment at 12 months

    The rate of freedom from repeat revascularization (surgical or endovascular) of the target lesion due to symptoms or worsening blood flow at 1, 6, and 12 months.

  5. Change in Ankle-Brachial Index (ABI) from Baseline

    Time frame: From enrollment to the end of treatment at 12 months

    Mean difference in ABI (normal range: 0.9-1.3) measurements between pre-procedure baseline and 12-month follow-up, assessed by standardized vascular laboratory protocols. Higher values indicate better perfusion.

  6. Change in Toe-Brachial Index (TBI) from Baseline

    Time frame: From enrollment to the end of treatment at 12 months

    Mean difference in TBI (normal >0.6) measurements between pre-procedure baseline and 12-month follow-up, assessed by standardized vascular laboratory protocols. Higher values indicate better perfusion.

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study 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

Acronym: CHOCO-PAD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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