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

• 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: NCT03505931
• 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 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):

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 Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-04-13
• Last Update Submitted: 2018-04-13
• Study First Posted: 2018-04-23
• Last Update Posted: 2018-04-23
• Study Start: 2018-05
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

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

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

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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)

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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
Primary patency	at 12 months	Absence of stenosis \>50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months

Secondary Outcome Measures

Name	Time	Method
Ruthford category	at 12 months	Rutherford category - symptom status by Rutherford category
stent fracture rate	at 12 months	stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections
Ankle-brachial index	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
target lesion revascularization	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

Trial Locations

Locations (1)

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