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 December 21, 2024

Completed

Keywords

Peripheral Artery Disease Femoropopliteal Drug Eluting Stent Restenosis

ClinConnect Summary

• 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)

Trial Officials

Young-Guk Ko, MD

Principal Investigator

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0