Search / Trial NCT06234280

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

Launched by YONSEI UNIVERSITY · Jan 23, 2024

Trial Information

Current as of October 04, 2024

Completed

Keywords

Peripheral Artery Disease Femoropopliteal Drug Eluting Stent Restenosis

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...

Gender

ALL

Eligibility criteria

  • 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)

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0