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

Critical Limb Ischemia (Rutherford Category 4 or 5) Clinical Trial

Official title: Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

Status Completed

Clinical 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 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia (Rutherford Category 4 or 5)
• Ischemia
• Moderate or Severe Claudication (Rutherford Category 2 or 3)
• Peripheral Arterial Disease
• Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions

• NCT number: NCT06234280
• Study type: Observational
• Source: Yonsei University
• Status: Completed
• Start date: May 11, 2018
• Completion date: December 31, 2023