Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease
NCT ID: NCT06234280
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2018-05-11
2023-12-31
Brief Summary
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* 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.
Detailed Description
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Screening (day 0):
1. Medical history and demography of the patient reviewed
2. Inclusion/exclusion eligibility will be checked
3. Physical examination (Height, weight)
4. Laboratory test
* BUN, eGFR, Cr.
* Hb, WBC, platelet
* Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)
5. Ankle-brachial index
6. Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography)
7. Medication
Enrollment (day 0):
1\) Written consent
Post PTA (Day 1 \~3):
1. Adverse event
2. Ankle-brachial index
3. Laboratory test:
* BUN, eGFR, Cr.
* Hb, WBC, platelet
4. 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)
1. Symptoms: Rutherford class
2. Ankle-brachial index
3. Concomitant medication
4. Adverse event Visit 3 (post-PTA 12 months ± 60 days)
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1. Symptoms: Rutherford class
2. Ankle-brachial index
3. Duplex ultrasound, CT, or catheter angiography
4. Biplane radiograph of femur for evaluation of stent fracture
5. Laboratory test
* 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)
1. Symptom: Rutherford category
2. Adverse events
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Eluvia
Patients treated with Eluvia stent
Implantation of Eluvia stent
Implantation of Eluvia stent
Interventions
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Implantation of Eluvia stent
Implantation of Eluvia stent
Eligibility Criteria
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Inclusion Criteria
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
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)
19 Years
85 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Young-Guk Ko, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Locations
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Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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1-2017-0095
Identifier Type: -
Identifier Source: org_study_id