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Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)

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ClinicalTrials.gov Identifier: NCT03505931
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
  • 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.

Condition or disease Intervention/treatment
Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions Moderate or Severe Claudication (Rutherford Category 2 or 3) Critical Limb Ischemia (Rutherford Category 4 or 5) Device: Implantation of Eluvia stent

Detailed Description:

Enrollment (day 0):

1) Written consent

Post PTA (Day 1 ~3):

  1. Symptom: Rutherford class
  2. Adverse event
  3. Ankle-brachial index
  4. Laboratory test: - eGFR, Cr, ALT, AST

    • Hb, WBC, platelet
  5. Concomitant medication

Regular Follow-up Visits

Visit 1 (post-PTA 30±14 days):

  1. Symptom: Rutherford class
  2. Physical examination
  3. Concomitant medication
  4. Adverse event
  5. 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):

  1. Symptoms: Rutherford class
  2. Physical examination
  3. Ankle-brachial index
  4. Concomitant medication
  5. Adverse event

Visit 3 (post-PTA 12 months ± 30 days): (Mandatory)

  1. Symptoms: Rutherford class
  2. Physical examination
  3. Ankle-brachial index
  4. Duplex ultrasound, CT, or catheter angiography
  5. Concomitant medication
  6. 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Group/Cohort Intervention/treatment
Eluvia
Patients treated with Eluvia stent
Device: Implantation of Eluvia stent
Implantation of Eluvia stent




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Ruthford category [ Time Frame: at 12 months ]
    Rutherford category - symptom status by Rutherford category

  3. 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

  4. stent fracture rate [ Time Frame: at 12 months ]
    stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505931


Locations
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Korea, Republic of
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Young-Guk Ko, MD    082-02-2228-8460    ygko@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Additional Information:

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03505931     History of Changes
Other Study ID Numbers: 1-2015-0095
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Peripheral artery disease
femoropopliteal
drug-eluting stent
restenosis
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Ischemia
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases