Symptomatic Peripheral Artery Disease With Femoropopliteal LesionsNCT03505931
Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
An observational study of Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions and Moderate or Severe Claudication (Rutherford Category 2 or 3), run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- What is being tested?
- Implantation of Eluvia stent
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2018to Apr 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
Young-Guk Ko, MD, 082-02-2228-8460, ygko@yuhs.ac
About this study
- 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.
Read the detailed description
Enrollment (day 0):
- 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
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Being tested
- Implantation of Eluvia stent
- Keywords
- Peripheral artery disease, femoropopliteal, drug-eluting stent, restenosis
- Medical subject headings
- Lymphoma, Follicular, Intermittent Claudication, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Eluvia stentDevice
Implantation of Eluvia stent
| Study group | Role | What they receive |
|---|---|---|
| Eluvia | Patients treated with Eluvia stent Receives: Device: Implantation of Eluvia stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Absence of stenosis >50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months
Measured: at 12 months
Secondary outcomes (4)
Ankle-brachial index
Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm
Measured: at 12 months
Ruthford category
Rutherford category - symptom status by Rutherford category
Measured: at 12 months
target lesion revascularization
Target lesion revascularization - accumulative rate of repeat interventions or surgery for the treatment of symptomatic restenosis (>50% stenosis) in the target lesion
Measured: at 12 months
stent fracture rate
stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study startMay 2018 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Peripheral Artery Disease With Femoropopliteal LesionsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505931
- Sponsor's protocol ID
- 1-2015-0095
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2018
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease (K-ELUVIA Registry)
- ClinicalTrials.gov ID
- NCT03505931
- Acronym / sponsor ID
- 1-2015-0095
- Conditions
- Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions, Moderate or Severe Claudication (Rutherford Category 2 or 3), Critical Limb Ischemia (Rutherford Category 4 or 5)
- Keywords
- Peripheral artery disease, femoropopliteal, drug-eluting stent, restenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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):
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eluvia | – | Device: Implantation of Eluvia stentPatients treated with Eluvia stent |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of Eluvia stentImplantation of Eluvia stent | Device | Eluvia |
Primary outcome
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
4 secondary outcomes
Ankle-brachial index
Time frame: at 12 months
Ruthford category
Time frame: at 12 months
target lesion revascularization
Time frame: at 12 months
stent fracture rate
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions and Moderate or Severe Claudication (Rutherford Category 2 or 3), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.