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

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).

Study Overview

• Status: Recruiting
• Conditions: Femoropopliteal Disease
• Intervention / Treatment: Device: Embolic Protection System

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Qihong Ni; Phone Number: 15801900772; Email: niqihong1989@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200217
      • Recruiting
      • Renji Hospital
      • Contact: Qihong Ni; Phone Number: 15801900772; Email: niqihong1989@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures

Description

Inclusion Criteria:

1. Age > 18 years
2. Rutherford classification 2-5
3. Patients with chronic femoropopliteal obstruction or thromboembolism who require debulking prior to other endovascular treatments.
4. 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
5. The guidewire needs to pass through the lesion
6. Life expectancy >24 months
7. Moderate to severe calcified lesions confirmed by imaging
8. For patients who receive intervention in both lower extremities, they may be enrolled in order of time of endovascular therapy
9. For combined aortoiliac artery lesions, recanalization of blood flow through endoluminal reconstruction of the vessel without more than 50% residual stenosis.

Exclusion Criteria:

1. Patients with stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or cardiac infarction within 3 months prior to enrollment
2. Patients with known allergy to heparin, aspirin, other antiplatelet drugs, contrast agents, etc.
3. 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;
4. Pregnant and lactating women
5. Patients who are unable or unwilling to participate in this trial
6. patients with Berger's disease
7. Patients who have undergone arterial bypass on the treated side

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Embolic Protection System during femoropopliteal endovascular debulking; Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking	Device: Embolic Protection System; Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day freedom from Major adverse events (MAEs)	Incidence of no major adverse events within 30 days. Major adverse event is defined as death; acute cardiac infarction; unplanned amputation; acute thrombosis of the target vessel; serious complications related to the filter, such as vessel perforation, detachment of the filter, and severe entrapment (type D,E,F); distal embolism with clear clinical signs (specifically, the presence of imaging evidence of clear distal embolism at the distal end of the filter, with severe manifestations of ischemia that require further endoluminal or surgical intervention for relief, or cause tissue damage/longer hospitalization).	30 days after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success Rate	Defined as: the filter passes through the lesion smoothly and is fully released distal to the lesion, and could be retrieved smoothly at the end of the treatment without serious vascular entrapment, distal embolization, or vascular perforation during release and retrieval	Immediately after intervention
Technical success rate	Defined as: successful revascularization without termination of operation due to device	Immediately after intervention

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: Shanghai Zhongshan Hospital; Huashan Hospital; Chengdu University of Traditional Chinese Medicine; Xuanwu Hospital, Beijing; Ruijin Hospital; First Affiliated Hospital of Zhejiang University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Qingdao Haici Hospital; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Affiliated Hospital of Nantong University; Xiamen Cardiovascular Hospital, Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Debulking; Embolic Protection System; Distal embolism
• Other Study ID Numbers: the EPISODE study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No