Peripheral Arterial Disease
Conditions
Keywords
Chocolate Balloon Catheter, Percutaneous Transluminal Angioplasty, Peripheral Arterial Disease
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
Interventions
DEVICEChocolate PTA Balloon Catheter
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.
Sponsors
First People's Hospital of Hangzhou
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion patency rate at 12 months post-procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of bailout stenting | 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). |
| Number of Participants with Improvement in Rutherford Clinical Category from Baseline | 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 |
| 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 | 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. |
| Change in Ankle-Brachial Index (ABI) from Baseline | 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. |
| Change in Toe-Brachial Index (TBI) from Baseline | 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. |
| Freedom from clinically driven Target Lesion Revascularization (TLR) at 1, 6, and 12 months | 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. |
Countries
China
Outcome results
None listed