Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

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)
• Interventions: Device: Implantation of Eluvia stent

• Registration Number: NCT06234280
• Lead Sponsor: Yonsei University

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 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.

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)

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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 Timeline

• Study Start: 2018-05-11
• Primary Completion: 2023-06-07
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eluvia	Implantation of Eluvia stent	Patients treated with Eluvia stent

Primary Outcome Measures

Name	Time	Method
Clinical patency	at 24 months	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.

Secondary Outcome Measures

Name	Time	Method
stent fracture rate	at 12 and 24 months	stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections
target lesion revascularization	at 12 and 24 months	Target lesion revascularization - accumulative rate of repeat interventions or surgery for the treatment of symptomatic restenosis (\>50% stenosis) in the target lesion
Ankle-brachial index	at 12 and 24 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	at 12 and 24 months	Rutherford category - symptom status by Rutherford category

Trial Locations

Locations (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of