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

N/AEnrolling By InvitationNCT06933992

First People's Hospital of Hangzhou171 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

171

Conditions

Peripheral Arterial Disease

Interventions

Chocolate PTA Balloon CatheterDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).