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

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

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

Status Not yet recruiting

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 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• 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: NCT03505931
• Study type: Observational [Patient Registry]
• Source: Yonsei University
• Status: Not yet recruiting
• Start date: May 2018
• Completion date: April 2021