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

Yonsei University

Status: Completed

Conditions: Critical Limb Ischemia (Rutherford Category 4 or 5); Moderate or Severe Claudication (Rutherford Category 2 or 3); Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions

Treatments: Device: Implantation of Eluvia stent

Study type: Observational

Funder types: Other

Identifiers

NCT06234280

1-2017-0095

Details and patient eligibility

About

• 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.

Full description

• Prospective, multi-center single-arm observational study

Screening (day 0):

Medical history and demography of the patient reviewed Inclusion/exclusion eligibility will be checked Physical examination (Height, weight)

Laboratory test

BUN, eGFR, Cr. Hb, WBC, platelet Lipid level (total cholesterol, LDL-C, triglyceride, HDL-C) Ankle-brachial index Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography) Medication

Enrollment (day 0):

1. Written consent

Post PTA (Day 1 ~3):

Adverse event Ankle-brachial index

Laboratory test:

BUN, eGFR, Cr. Hb, WBC, platelet 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)

Symptoms: Rutherford class Ankle-brachial index Concomitant medication Adverse event Visit 3 (post-PTA 12 months ± 60 days) Symptoms: Rutherford class Ankle-brachial index Duplex ultrasound, CT, or catheter angiography Biplane radiograph of femur for evaluation of stent fracture 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)

Symptom: Rutherford category Adverse events

Enrollment: 100 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

Eluvia

Description:

Patients treated with Eluvia stent

Treatment:

Device: Implantation of Eluvia stent