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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03505931
• Other study ID #: 1-2015-0095
• Status: Not yet recruiting
• First received: April 13, 2018
• Last updated: April 13, 2018
• Start date: May 2018
• Est. completion date: April 2021

Study information

• Verified date: April 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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)

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

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	Primary patency	Absence of stenosis >50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months	at 12 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 months
Secondary	Ruthford category	Rutherford category - symptom status by Rutherford category	at 12 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 months
Secondary	stent fracture rate	stent fracture rate - incidence of stent fracture by radiographs or fluoroscopy in 2 different projections	at 12 months