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

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Eluvia
Patients treated with Eluvia stent
Device: Implantation of Eluvia stent
Implantation of Eluvia stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-2015-0095

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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