Observing the effects of Eluvia stents in patients with femoral-popliteal artery issues
Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
This study is testing how well Eluvia stents work for people with leg artery problems and whether they improve quality of life over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05522218 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective observational study aims to enroll 400 patients suffering from peripheral arterial disease affecting the femoral-popliteal segment who will receive Eluvia drug-eluting stents. Participants will be monitored for two years to assess various outcomes, including technical success rates, target lesion patency rates, improvements in quality of life, and the costs associated with the stent implantation. The study seeks to provide valuable insights into the effectiveness and economic impact of using Eluvia stents in this patient population.
Who should consider this trial
Good fit: Ideal candidates include individuals with Rutherford Stage 2-5 peripheral arterial disease and significant stenosis or occlusion of the femoropopliteal artery.
Not a fit: Patients with a life expectancy of less than one year, severe limb infections, or those who are unable to participate in the observational study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for patients with femoral-popliteal artery lesions, enhancing their quality of life and clinical outcomes.
How similar studies have performed: While this study employs a well-known intervention, the specific observational approach and outcomes being assessed may provide novel insights into the use of Eluvia stents.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.