Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-24 @ 3:16 PM
NCT ID:
NCT06933992
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06933992
Study Brief:
Protocol Section:
NCT06933992