NCT06234280Completed
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
Source: ClinicalTrials.gov · Last updated 31 Jan 2024
Brief summary (registry, in English)
* Prospective, multi-center single-arm observational study * A total of 100 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included. * Patients will be followed clinically for 24 months after the procedure. * An imaging study (duplex ultrasound, CT or catheter-based angiography) follow-up according to participating hospital's protocol will be performed at 12 months. * Ankle-brachial index, symptom status and presence of stent fracture will be evaluated at 12 months.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 23 Jan 2024
- Start date
- 11 May 2018
- Primary completion date
- 7 Jun 2023
- Lead sponsor
- Yonsei University
- NCT number
- NCT06234280
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 11 May 2018 to the primary completion date, 7 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
Other illness
- Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
- Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
Lab values
- LVEF \< 40% or clinically overt congestive heart failure
Age
- Age \> 85 years
Other
- Acute critical limb ischemia
- Severe critical limb ischemia (Rutherford category 6)
- Bypass graft lesions
- Severe hepatic dysfunction (\> 3 times normal reference values)
- Pregnant women or women with potential childbearing
- Life expectancy \<1 year due to comorbidity
Who the study is looking for
- Age 19 years of older
- Symptomatic peripheral artery disease:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4-5)
- Femoropopliteal artery lesions with stenosis \> 50%
- ABI \< 0.9 before treatment
- Patents treated with ELUVIA stent for femoropopliteal artery disease
- Patients with signed informed consent
Age in the registry: 19 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.