Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures

Recruiting now

Conditions studied: Femoropopliteal Disease

In brief

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).

Key facts

Study ID

NCT07282301

Run by

RenJi Hospital

People needed

150

Starts

2025-10-20

Expected to finish

2026-12-31

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• For combined aortoiliac artery lesions, recanalization of blood flow through endoluminal reconstruction of the vessel without more than 50% residual stenosis.

You may not qualify if…

• 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;
• Pregnant and lactating women
• Patients who are unable or unwilling to participate in this trial
• patients with Berger's disease
• Patients who have undergone arterial bypass on the treated side

Where it is running

• Renji Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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