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

NCT03505931 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2018-04-23

No results posted yet for this study

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.

Conditions

  • Symptomatic Peripheral Artery Disease With Femoropopliteal Lesions
  • Moderate or Severe Claudication (Rutherford Category 2 or 3)
  • Critical Limb Ischemia (Rutherford Category 4 or 5)

Interventions

DEVICE

Implantation of Eluvia stent

Implantation of Eluvia stent

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03505931 on ClinicalTrials.gov