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

NCT ID: NCT03505931

Last Updated: 2018-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2021-04-30

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

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)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Eluvia

Patients treated with Eluvia stent

Implantation of Eluvia stent

Intervention Type: DEVICE

Implantation of Eluvia stent

Interventions

Implantation of Eluvia stent

Implantation of Eluvia stent

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Facility Contacts

Young-Guk Ko, MD

Role: primary

ygko@yuhs.ac

082-02-2228-8460

Other Identifiers

1-2015-0095

Identifier Type: -

Identifier Source: org_study_id