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

April 13, 2018 updated by: Yonsei University
  • 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

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

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

April 13, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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