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

NCT07282301 | Recruiting DMC FDA Device

• 1 other identifier: the EPISODE study
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Femoropopliteal Disease

Keywords

Embolic Protection System; Distal embolism; Debulking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Device Success Rate

  Immediately after intervention

• Technical success rate

  Immediately after intervention

Study Arms (1)

Embolic Protection System during femoropopliteal endovascular debulking

Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking

Device: Embolic Protection System

Interventions

Embolic Protection System DEVICE

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

Embolic Protection System during femoropopliteal endovascular debulking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

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

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200217, China

RECRUITING

Central Study Contacts

Qihong Ni

CONTACT

15801900772; niqihong1989@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)