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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

Tracking Information
First Submitted Date April 13, 2018
First Posted Date April 23, 2018
Last Update Posted Date April 23, 2018
Estimated Study Start Date May 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 13, 2018)
  • 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
  • Ruthford category [ Time Frame: at 12 months ]
    Rutherford category - symptom status by Rutherford category
  • 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
  • stent fracture rate [ Time Frame: at 12 months ]
    stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
Official Title Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
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.
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
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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
Condition
  • Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions
  • Moderate or Severe Claudication (Rutherford Category 2 or 3)
  • Critical Limb Ischemia (Rutherford Category 4 or 5)
Intervention Device: Implantation of Eluvia stent
Implantation of Eluvia stent
Study Groups/Cohorts Eluvia
Patients treated with Eluvia stent
Intervention: Device: Implantation of Eluvia stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 13, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03505931
Other Study ID Numbers 1-2015-0095
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date April 2018