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Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02698358
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
  • Prospective, single-arm, multi-center registry study
  • A total of 150 subjects with iliac artery disease who meet all inclusion and exclusion criteria will be included.
  • Patients will be followed clinically for 12 months after the procedure.
  • Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months.
  • Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months.
  • Quality of life by standardized questionnaires (at baseline & at 1 & 12 months)

Condition or disease Intervention/treatment
Iliac Artery Disease Device: Epic stent (Boston Scientific)

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : December 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Group/Cohort Intervention/treatment
K-EPIC
Patients with femoropopliteal artery disease undergoing endovascular therapy using Epic stent (Boston Scientific).
Device: Epic stent (Boston Scientific)



Primary Outcome Measures :
  1. Primary patency [ Time Frame: 12 months ]
    Absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months


Secondary Outcome Measures :
  1. Target lesion revascularization rate [ Time Frame: 12 months ]
  2. Stent fracture rate [ Time Frame: 12 months ]
  3. Quality of life by standardized questionnaires [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Iliac artery disease
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)
  3. Iliac artery lesions with stenosis > 50%
  4. ABI <0.9
  5. Patients with signed informed consent

Exclusion Criteria:

  1. Acute critical limb ischemia
  2. Severe critical limb ischemia (Rutherford category 5 or 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 aorta or the ipsilateral iliac arteries (more than 50% stenosis or occlusion)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698358


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02698358    
Other Study ID Numbers: 1-2015-0075
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yonsei University:
Peripheral artery disease, Iliac artery, nitinol stent, restenosis