NCT05522218 Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
| NCT ID | NCT05522218 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Vascular Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2022-08-01 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a multicenter, prospective, observational study, aiming to enroll 400 patients with peripheral arterial disease in the femoral-popliteal segment implanted with Eluvia stent. Each patient was followed up for 2 years. The technical success rate, target lesion patency rate, quality of life improvement, cost of Eluvia stent implantation, and other outcomes will be analysed.
Eligibility Criteria
Inclusion Criteria: 1. Rutherford Stage 2-5. 2. At least 90% stenosis or occlusion of the femoropopliteal artery. 3. Eluvia stents are used for target lesions. 4. Agree and sign the informed consent form Exclusion Criteria: 1. Life expectancy is less than 1 year. 2. Those with severe infection and gangrene of the limbs or those with tissue defects beyond the plane of the toes (ie major tissue loss), who may undergo major amputation even if the blood vessels are opened. 3. Patients and their families are reluctant to join the observational study, or have difficulty in communication and are unable to assess the quality of life. 4. Patients with in-stent restenosis of the femoral popliteal artery. 5. Patients with acute arterial thrombosis.
Frequently Asked Questions
Who can join the NCT05522218 clinical trial?
This trial is open to participants of all sexes, studying Vascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05522218 currently recruiting?
Yes, NCT05522218 is actively recruiting participants. Visit ClinicalTrials.gov or contact First Affiliated Hospital of Zhejiang University to inquire about joining.
Where is the NCT05522218 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05522218 clinical trial?
NCT05522218 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 400 participants.