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* 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.
• Prospective, multi-center single-arm observational study 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) <!-- --> 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
Age
19 - 85 years
Sex
ALL
Healthy Volunteers
No
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
Start Date
May 11, 2018
Primary Completion Date
June 7, 2023
Completion Date
December 31, 2023
Last Updated
January 31, 2024
100
ACTUAL participants
Implantation of Eluvia stent
DEVICE
Lead Sponsor
Yonsei University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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