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Clinical Trials/NCT03505931
NCT03505931UnknownNot Applicable

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

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

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
Primary 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 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.

Detailed 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
  1. Concomitant medication

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) 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)

Outcomes

Primary Outcomes

Primary patency

Time Frame: at 12 months

Absence of stenosis \>50% by an follow-up imaging study (duplex ultrasound, CT or catheter-based angiography) at 12 months

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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