Eluvia DES for the Patients with Femoropopliteal Artery Lesions.
Clinical Effectiveness and Health Economic Evaluation of Eluvia Drug-eluting Stent in the Treatment of Femoropopliteal Artery Lesions
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedSeptember 27, 2024
September 1, 2024
3 years
August 24, 2022
September 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
The change of Rutherfor classification
Comparison of preoperative Rutherford classification and postoperative Rutherford classification at 24 months
24 months
F-TLR
free of target vascular reconstruction
24 months
limb salvage rate
Proportion of patients without ambutation
24 months
Secondary Outcomes (7)
Technical success rate
1 month
the patency target lesion
24 months
mortality rate
24 months
the life quality change
24 months
the life quality change
24 months
- +2 more secondary outcomes
Interventions
Eluvia drug eluting stent for peripheral arterial disease
Eligibility Criteria
peripheral arterial disease patients implanted with Eluvia stent
You may qualify if:
- Rutherford Stage 2-5.
- At least 90% stenosis or occlusion of the femoropopliteal artery.
- Eluvia stents are used for target lesions.
- Agree and sign the informed consent form
You may not qualify if:
- Life expectancy is less than 1 year.
- 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.
- 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.
- Patients with in-stent restenosis of the femoral popliteal artery.
- Patients with acute arterial thrombosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated chief physician
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 30, 2022
Study Start
August 1, 2022
Primary Completion
August 1, 2025
Study Completion
December 31, 2025
Last Updated
September 27, 2024
Record last verified: 2024-09