Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

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

— K-ELUVIA  

Official title:

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06234280
• Other study ID #: 1-2017-0095
• Status: Completed
• Start date: May 11, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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)

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

Intervention

Device:
• Implantation of Eluvia stent
Implantation of Eluvia stent

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical patency	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.	at 24 months
Secondary	Ankle-brachial index	Ankle-brachial index defined as the ratio of the blood pressure at the ankle to the blood pressure in the upper arm	at 12 and 24 months
Secondary	Ruthford category	Rutherford category - symptom status by Rutherford category	at 12 and 24 months
Secondary	target lesion revascularization	Target lesion revascularization - accumulative rate of repeat interventions or surgery for the treatment of symptomatic restenosis (>50% stenosis) in the target lesion	at 12 and 24 months
Secondary	stent fracture rate	stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections	at 12 and 24 months