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• Prospective, multi-center single-arm observational study
Screening (day 0):
Medical history and demography of the patient reviewed
Inclusion/exclusion eligibility will be checked
Physical examination (Height, weight)
Laboratory test
Ankle-brachial index
Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography)
Medication
Enrollment (day 0):
1) Written consent
Post PTA (Day 1 ~3):
Adverse event
Ankle-brachial index
Laboratory test:
Concomitant medication Regular Follow-up Visits Visit 1 (post-PTA 30±14 days)
1) Symptom: Rutherford class 2) Laboratory test:
BUN, eGFR, Cr.
Hb, WBC, platelet 3) Concomitant medication 4) Adverse event Visit 2 (post-PTA 6 months ± 30 days)
BUN, eGFR, Cr.
Hb, WBC, platelet
Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C) 6)Concomitant medication 7) Adverse event Visit4 (post-PTA 24 months ± 60 days)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eluvia | Patients treated with Eluvia stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of Eluvia stent | Device | Implantation of Eluvia stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical patency | 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. | at 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ankle-brachial index | Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm | at 12 and 24 months |
| Ruthford category | Rutherford category - symptom status by Rutherford category |
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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:
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Symptomatic peripheral artery disease with femoropopliteal lesions:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Guk Ko, MD | Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Seoul | South Korea |
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| at 12 and 24 months |
| target lesion revascularization | Target lesion revascularization - accumulative rate of repeat interventions or surgery for the treatment of symptomatic restenosis (>50% stenosis) in the target lesion | at 12 and 24 months |
| stent fracture rate | stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections | at 12 and 24 months |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D007383 | Intermittent Claudication |
| D000089802 | Chronic Limb-Threatening Ischemia |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D007511 | Ischemia |
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