Clinical trial · Observational
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
- 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 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.
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
- Clinical patency
- timeFrame
- at 24 months
- description
- Freedom from symptom worsening, as indicated by an increase in Rutherford category accompanied by a ≥ 0.15 decrease in ABI or \> 50% restenosis on imaging studies at 24 months.
Secondary outcomes (4)
- measure
- Ankle-brachial index
- timeFrame
- at 12 and 24 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: 1. Age 19 years of older 2. Symptomatic peripheral artery disease: * Moderate or severe claudication (Rutherford category 2 or 3) * Critical limb ischemia (Rutherford category 4-5) 3. Femoropopliteal artery lesions with stenosis \> 50% 4. ABI \< 0.9 before treatment 5. Patents treated with ELUVIA stent for femoropopliteal artery disease 6. Patients with signed informed consent Exclusion Criteria: 1. Acute critical limb ischemia 2. Severe critical limb ischemia (Rutherford category 6) 3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents 4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment) 5. Bypass graft lesions 6. Age \> 85 years 7. Severe hepatic dysfunction (\> 3 times normal reference values) 8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis 9. LVEF \< 40% or clinically overt congestive heart failure 10. Pregnant women or women with potential childbearing 11. Life expectancy \<1 year due to comorbidity 12. Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
References
Publications (0)
Data not yet available