An observational study in Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3) and Critical Limb Ischemia (Rutherford Category 4 or 5), sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by Yonsei University · Observational
Enrollment (day 0):
Post PTA (Day 1 \~3):
Laboratory test: - eGFR, Cr, ALT, AST
Regular Follow-up Visits
Visit 1 (post-PTA 30±14 days):
Laboratory test:
Visit 2 (post-PTA 6 months ± 30 days):
Visit 3 (post-PTA 12 months ± 30 days): (Mandatory)
Adverse event 7) Biplane radiograph of femur for evaluation of stent fracture 8) Laboratory test: - AC glucose, eGFR, Cr, ALT, AST
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 100 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Symptomatic peripheral artery disease with femoropopliteal lesions:
Exclusion Criteria:
Patients treated with Eluvia stent
Device: Implantation of Eluvia stent
Implantation of Eluvia stent
Primary patency
Absence of stenosis \>50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months
Time frame: at 12 months
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
Time frame: at 12 months
Ruthford category
Rutherford category - symptom status by Rutherford category
Time frame: at 12 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
Time frame: at 12 months
stent fracture rate
stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections
Time frame: at 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Yonsei University