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

NCT06933992 | Enrolling By Invitation DMC

• 1 other identifier: NV-001-HZFH
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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

Conditions

Peripheral Arterial Disease

Keywords

Chocolate Balloon Catheter; Percutaneous Transluminal Angioplasty; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Target lesion patency rate at 12 months post-procedure

  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).

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (6)

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

  From enrollment to the end of treatment at 12 months

• Rate of bailout stenting

  From enrollment to the end of treatment at 12 months

• Number of Participants with Improvement in Rutherford Clinical Category from Baseline

  From enrollment to the end of treatment at 12 months

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

  From enrollment to the end of treatment at 12 months

• Change in Ankle-Brachial Index (ABI) from Baseline

  From enrollment to the end of treatment at 12 months

Study Arms (1)

Chocolate PTA for PAD

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.

Device: Chocolate PTA Balloon Catheter

Interventions

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.

Chocolate PTA for PAD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, China

Location

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Related Links

• Description the protocol of the study

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Meng Xiaohu, MS

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 18, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)