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Recruiting NCT07282301

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

— Observational Femoropopliteal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Embolic Protection System.
Who it may be relevant to
Registry conditions: Femoropopliteal Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

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

Primary outcome measures

  • 30-day freedom from Major adverse events (MAEs) [Time frame: 30 days after intervention]
Secondary outcome measures (2)
  • Device Success Rate [Time frame: Immediately after intervention]
  • Technical success rate [Time frame: Immediately after intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Renji Hospital — Shanghai

Identifiers

NCT: NCT07282301 · the EPISODE study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗