Embolic protection to prevent distal embolism during femoropopliteal debulking procedures.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Renji Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Qihong Ni
• Email: niqihong1989@163.com
• Phone: 15801900772

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.