Femoropopliteal DiseaseNCT07282301
Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures
An observational study of Femoropopliteal Disease, run by RenJi Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal Disease
- What is being tested?
- Embolic Protection System
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200217
Qihong Ni, 15801900772, niqihong1989@163.com
About this study
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
- Being tested
- Embolic Protection System
- Keywords
- Embolic Protection System, Distal embolism, Debulking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embolic Protection SystemDevice
Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
| Study group | Role | What they receive |
|---|---|---|
| Embolic Protection System during femoropopliteal endovascular debulking | Using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking Receives: Device: Embolic Protection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days after intervention
Secondary outcomes (2)
Device Success Rate
Defined as: the filter passes through the lesion smoothly and is fully released distal to the lesion, and could be retrieved smoothly at the end of the treatment without serious vascular entrapment, distal embolization, or vascular perforation during release and retrieval
Measured: Immediately after intervention
Technical success rate
Defined as: successful revascularization without termination of operation due to device
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start20 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, First Affiliated Hospital of Zhejiang University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital, Shanghai Zhongshan Hospital, Qingdao Haici Hospital, Ruijin Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Chengdu University of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Affiliated Hospital of Nantong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282301
- Sponsor's protocol ID
- the EPISODE study
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Outcomes of the Embolic Protection System in Preventing Distal Embolism During Femoropopliteal Debulking Procedures
- ClinicalTrials.gov ID
- NCT07282301
- Acronym / sponsor ID
- the EPISODE study
- Conditions
- Femoropopliteal Disease
- Keywords
- Embolic Protection System, Distal embolism, Debulking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, First Affiliated Hospital of Zhejiang University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital, Shanghai Zhongshan Hospital, Qingdao Haici Hospital, Ruijin Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Chengdu University of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Affiliated Hospital of Nantong University
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolic Protection System during femoropopliteal endovascular debulking | – | Device: Embolic Protection SystemUsing Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients using Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embolic Protection SystemUsing Embolic Protection System for preventing distal embolism during femoropopliteal endovascular debulking procedures | Device | Embolic Protection System during femoropopliteal endovascular debulking |
Primary outcome
30-day freedom from Major adverse events (MAEs)
Time frame: 30 days after intervention
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).
2 secondary outcomes
Device Success Rate
Time frame: Immediately after intervention
Technical success rate
Time frame: Immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoropopliteal Disease, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qihong Ni (15801900772, niqihong1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day freedom from Major adverse events (MAEs) (time frame: 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.