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Clinical Trials/NCT06234280
NCT06234280CompletedNot Applicable

Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease

Yonsei University1 site in 1 country100 target enrollmentStarted: May 11, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Clinical patency
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed 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)
  1. Ankle-brachial index
  2. Imaging study (CT/MR angiography, Doppler ultrasound, or catheter angiography)
  3. Medication

Enrollment (day 0):

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 19 years of older
  • •Symptomatic peripheral artery disease:
  • •Moderate or severe claudication (Rutherford category 2 or 3)
  • •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)

Outcomes

Primary Outcomes

Clinical patency

Time Frame: at 24 months

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.

Secondary Outcomes

  • stent fracture rate(at 12 and 24 months)
  • target lesion revascularization(at 12 and 24 months)
  • Ankle-brachial index(at 12 and 24 months)
  • Ruthford category(at 12 and 24 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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