Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (NCT06234280) | Clinical Trial Compass
CompletedNot Applicable
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
South Korea100 participantsStarted 2018-05-11
Plain-language summary
* 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.
Who can participate
Age range19 Years – 85 Years
SexALL
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Inclusion criteria
✓. Age 19 years of older
✓. Symptomatic peripheral artery disease:
✓. 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)