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

• 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 24 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: Completed
• 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)
• Intervention / Treatment: Device: Implantation of Eluvia stent

Detailed Description

• Prospective, multi-center single-arm observational study

Screening (day 0):

1. Medical history and demography of the patient reviewed
2. Inclusion/exclusion eligibility will be checked
3. Physical examination (Height, weight)

4. Laboratory test

   • BUN, eGFR, Cr.
   • Hb, WBC, platelet
   • Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C)
5. Ankle-brachial index
6. Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography)
7. Medication

Enrollment (day 0):

1) Written consent

Post PTA (Day 1 ~3):

1. Adverse event
2. Ankle-brachial index

3. Laboratory test:

   • BUN, eGFR, Cr.
   • Hb, WBC, platelet
4. Concomitant medication Regular Follow-up Visits Visit 1 (post-PTA 30±14 days)

1) Symptom: Rutherford class 2) Laboratory test:

• BUN, eGFR, Cr.

• Hb, WBC, platelet 3) Concomitant medication 4) Adverse event Visit 2 (post-PTA 6 months ± 30 days)

  1. Symptoms: Rutherford class
  2. Ankle-brachial index
  3. Concomitant medication
  4. Adverse event Visit 3 (post-PTA 12 months ± 60 days)
  1. Symptoms: Rutherford class
  2. Ankle-brachial index
  3. Duplex ultrasound, CT, or catheter angiography
  4. Biplane radiograph of femur for evaluation of stent fracture
  5. Laboratory test
• BUN, eGFR, Cr.
• Hb, WBC, platelet

• Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C) 6)Concomitant medication 7) Adverse event Visit4 (post-PTA 24 months ± 60 days)

  1. Symptom: Rutherford category
  2. Adverse events

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

Inclusion Criteria:

1. Age 19 years of older

2. Symptomatic peripheral artery disease:

   • Moderate or severe claudication (Rutherford category 2 or 3)
   • Critical limb ischemia (Rutherford category 4-5)
3. Femoropopliteal artery lesions with stenosis > 50%
4. ABI < 0.9 before treatment
5. Patents treated with ELUVIA stent for femoropopliteal artery disease
6. Patients with signed informed consent

Exclusion Criteria:

1. Acute critical limb ischemia
2. Severe critical limb ischemia (Rutherford category 6)
3. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, cilostazol, or contrast agents
4. In-stent restenosis lesions (Restenosis lesions without previously implanted stents are eligible to the enrollment)
5. Bypass graft lesions
6. Age > 85 years
7. Severe hepatic dysfunction (> 3 times normal reference values)
8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
9. LVEF < 40% or clinically overt congestive heart failure
10. Pregnant women or women with potential childbearing
11. Life expectancy <1 year due to comorbidity
12. Untreated proximal inflow disease of the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical patency	Freedom from symptom worsening, as indicated by an increase in Rutherford category accompanied by a ≥ 0.15 decrease in ABI or > 50% restenosis on imaging studies at 24 months.	at 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at 12 and 24 months
Ruthford category	Rutherford category - symptom status by Rutherford category	at 12 and 24 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	at 12 and 24 months
stent fracture rate	stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections	at 12 and 24 months

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Young-Guk Ko, MD, Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2018
• Primary Completion (Actual): June 7, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: drug-eluting stent; Peripheral artery disease; restenosis; femoropopliteal
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Ischemia; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: 1-2017-0095

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No