Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolis… (NCT07282301) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures
China150 participantsStarted 2025-10-20
Plain-language summary
Patients with femoropopliteal arterial lesions requiring debulking procedures. The objective of this study is Evaluation of the clinical outcomes of the Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures (The EPISODE study).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \> 18 years
✓. Rutherford classification 2-5
✓. Patients with chronic femoropopliteal obstruction or thromboembolism who require debulking prior to other endovascular treatments.
✓. Patients who understand the purpose of this study, participate in the study voluntarily, sign the informed consent and are willing to receive follow-up visits
✓. The guidewire needs to pass through the lesion
✓. Life expectancy \>24 months
✓. Moderate to severe calcified lesions confirmed by imaging
✓. For patients who receive intervention in both lower extremities, they may be enrolled in order of time of endovascular therapy
Exclusion criteria
✕. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment
✕. Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
✕. Patients who have been treated with drugs that interfere with this clinical trial or intraoperatively with other special vascular bed preparation devices, such as plaque volume reduction devices, special balloons, etc., within the last 3 months;