Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)
NCT ID: NCT02701816
Last Updated: 2020-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2016-01-31
2021-01-31
Brief Summary
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* A total of 150 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.
* 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)
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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K-INNOVA
Patients with femoropopliteal artery disease undergoing endovascular therapy using Innova stent (Boston Scientific).
innova stent (Boston scientific)
Interventions
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innova stent (Boston scientific)
Eligibility Criteria
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Inclusion Criteria
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
5. Patients with signed informed consent
Exclusion Criteria
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)
19 Years
85 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Facility Contacts
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Other Identifiers
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1-2015-0074
Identifier Type: -
Identifier Source: org_study_id
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