Clinical trial · Observational
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* 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 12 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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Critical Limb Ischemia (Rutherford Category 4 or 5) | — | UNRESOLVED | — |
| Moderate or Severe Claudication (Rutherford Category 2 or 3) | — | UNRESOLVED | — |
| Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implantation of Eluvia stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Eluvia
- description
- Patients treated with Eluvia stent
- interventionNames
- Device: Implantation of Eluvia stent
Primary outcomes (1)
- measure
- Primary patency
- timeFrame
- at 12 months
- description
- Absence of stenosis \>50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months
Secondary outcomes (4)
- measure
- Ankle-brachial index
- timeFrame
- at 12 months
- description
- Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age 19 years of older * Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) and 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 Exclusion Criteria: * Acute critical limb ischemia * Severe critical limb ischemia (Rutherford category 6) * Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents * In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment) * Bypass graft lesions * Age \> 85 years * Severe hepatic dysfunction (\> 3 times normal reference values) * Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis * LVEF \< 40% or clinically overt congestive heart failure * Pregnant women or women with potential childbearing * Life expectancy \<1 year due to comorbidity * Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
References
Publications (0)
Data not yet available