- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03505931
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
- 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 12 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Enrollment (day 0):
1) Written consent
Post PTA (Day 1 ~3):
- Symptom: Rutherford class
- Adverse event
- Ankle-brachial index
Laboratory test: - eGFR, Cr, ALT, AST
- Hb, WBC, platelet
- Concomitant medication
Regular Follow-up Visits
Visit 1 (post-PTA 30±14 days):
- Symptom: Rutherford class
- Physical examination
- Concomitant medication
- Adverse event
Laboratory test:
- AC glucose, eGFR, Cr, ALT, AST
- Hb, WBC, platelet
- Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)
- HbA1c in case of DM
- hsCRP
Visit 2 (post-PTA 6 months ± 30 days):
- Symptoms: Rutherford class
- Physical examination
- Ankle-brachial index
- Concomitant medication
- Adverse event
Visit 3 (post-PTA 12 months ± 30 days): (Mandatory)
- Symptoms: Rutherford class
- Physical examination
- Ankle-brachial index
- Duplex ultrasound, CT, or catheter angiography
- Concomitant medication
Adverse event 7) Biplane radiograph of femur for evaluation of stent fracture 8) Laboratory test: - AC glucose, eGFR, Cr, ALT, AST
- Hb, WBC, platelet
- Lipid level (total cholesterol, LDL-C,triglyceride, HDL-C)
- HbA1c in case of DM
- hsCRP
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
-
Contact:
- Young-Guk Ko, MD
- Phone Number: 082-02-2228-8460
- Email: ygko@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Symptomatic peripheral artery disease with femoropopliteal lesions:
- Moderate or severe claudication (Rutherford category 2 or 3)
- Critical limb ischemia (Rutherford category 4 or 5) Age: ≥19 years, but not older than 85 years
Description
Inclusion Criteria:
- Age 19 years of older
- Symptomatic peripheral artery disease: Moderate or severe claudication (Rutherford category 2 or 3) and Critical limb ischemia (Rutherford category 4-5)
- 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)
- Bypass graft lesions
- Age > 85 years
- Severe hepatic dysfunction (> 3 times normal reference values)
- Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- LVEF < 40% or clinically overt congestive heart failure
- Pregnant women or women with potential childbearing
- Life expectancy <1 year due to comorbidity
- Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Eluvia
Patients treated with Eluvia stent
|
Implantation of Eluvia stent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary patency
Time Frame: at 12 months
|
Absence of stenosis >50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months
|
at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ankle-brachial index
Time Frame: at 12 months
|
Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm
|
at 12 months
|
Ruthford category
Time Frame: at 12 months
|
Rutherford category - symptom status by Rutherford category
|
at 12 months
|
target lesion revascularization
Time Frame: at 12 months
|
Target lesion revascularization - accumulative rate of repeat interventions or surgery for the treatment of symptomatic restenosis (>50% stenosis) in the target lesion
|
at 12 months
|
stent fracture rate
Time Frame: at 12 months
|
stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections
|
at 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2015-0095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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