Actively Recruiting
Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures
Led by RenJi Hospital · Updated on 2025-12-15
150
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
Sponsors
R
RenJi Hospital
Lead Sponsor
X
Xuanwu Hospital, Beijing
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Rutherford classification 2-5
- Chronic femoropopliteal obstruction or thromboembolism requiring debulking before other endovascular treatments
- Understands the study purpose, voluntarily agrees to participate, signs informed consent, and agrees to follow-up visits
- Guidewire can pass through the lesion
- Life expectancy longer than 24 months
- Moderate to severe calcified lesions confirmed by imaging
- If both lower extremities require intervention, enrollment follows the timing of endovascular therapy
- For combined aortoiliac artery lesions, blood flow restored with less than 50% residual narrowing after vessel reconstruction
You will not qualify if you...
- Stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or heart attack within 3 months before enrollment
- Known allergy to heparin, aspirin, other antiplatelet drugs, or contrast agents
- Treatment with interfering drugs or special vascular devices within the last 3 months
- Pregnant or breastfeeding women
- Unable or unwilling to participate in the study
- Diagnosis of Berger's disease
- Previous arterial bypass surgery on the treated side
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200217
Actively Recruiting
Research Team
Q
Qihong Ni
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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