Embolic protection to prevent distal embolism during femoropopliteal debulking procedures.

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

This study will test whether using an embolic protection system during femoropopliteal debulking can reduce distal embolism in adults with chronic femoropopliteal lesions.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07282301 on ClinicalTrials.gov

What this trial studies

This is an observational study led by RenJi Hospital that will enroll adults who undergo femoropopliteal debulking with an embolic protection device. Clinical and procedural data, including imaging-confirmed lesion characteristics and whether distal embolism occurs, will be recorded. Patients will be followed with scheduled visits to capture short- and mid-term outcomes, complications, and need for additional endovascular treatments. The study focuses on patients with moderate to severe calcified femoropopliteal lesions and requires the lesion to be crossable with a guidewire.

Who should consider this trial

Good fit: Adults over 18 with Rutherford class 2–5 chronic femoropopliteal obstruction or thromboembolism who require debulking, have moderate to severe calcification, a passable guidewire, and expected survival beyond 24 months.

Not a fit: Patients with recent major bleeding or ischemic events (stroke, cerebral hemorrhage, gastrointestinal hemorrhage, or myocardial infarction within 3 months), known heparin allergy, inability to cross the lesion, or limited life expectancy are unlikely to benefit from this procedure in the study context.

Why it matters

Potential benefit: If successful, using the embolic protection system could lower the risk of distal embolism and related complications during femoropopliteal debulking, improving procedural safety.

How similar studies have performed: Embolic protection devices have shown benefit in some carotid and peripheral vascular procedures, but high-quality evidence specifically for femoropopliteal debulking is limited and mainly from small or nonrandomized series.

Eligibility criteria

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

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Qihong Ni

Conditions Femoropopliteal Disease; Embolic Protection System; Distal embolism; Debulking