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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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2007-03-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cutting balloon
Cutting balloon
Cutting balloon
Cutting balloon
Sirolimus-eluting stent
Sirolimus-eluting stent
Sirolimus-eluting stent
Sirolimus-eluting stent
Cutting balloon
Cutting balloon
Sirolimus-eluting stent
Sirolimus-eluting stent
Interventions
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Cutting balloon
Cutting balloon
Sirolimus-eluting stent
Sirolimus-eluting stent
Eligibility Criteria
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Inclusion Criteria
2. Restenosis after drug-eluting stents (\>50% by visual estimate)
3. Lesion length \< 10 mm (focal ISR)
4. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria
* Heparin
* Aspirin
* Both Clopidogrel and TIclopidine
* Sirolimus eluting stent
* Stainless steel and/or
* Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
2. Systemic (intravenous) Sirolimus use within 12 months.
3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
6. Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
7. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
9. Patients with EF\<30%.
10. Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
11. Creatinine level 3.0mg/dL or dependence on dialysis.
12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
13. Patients with left main stem stenosis and left main in-stent restenosis created by DES(\>50% by visual estimate)
18 Years
ALL
No
Sponsors
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CardioVascular Research Foundation, Korea
OTHER
Seung-Jung Park
OTHER
Responsible Party
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Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Principal Investigators
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Seung-Jung Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Locations
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Soonchunhyang University Bucheon Hospital
Bucheon-si, , South Korea
Choeng Ju St.Mary's Hospital
Choeng Ju, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Asan Medical Center
Gangneung, , South Korea
DongGuk University Gyongju Hospital
Gyongju, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Kwangju Christian Hospital
Kwangju, , South Korea
Inje University Pusan Paik Hospital
Pusan, , South Korea
Hallym University Sacred Heart Hospital,
Pyeongchon, , South Korea
Asan Medical Center
Seoul, , South Korea
Hangang Sacred Heart Hospital
Seoul, , South Korea
Kyungsang University Hospital
Seoul, , South Korea
Seoul Veterans Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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Other Identifiers
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20070041
Identifier Type: -
Identifier Source: org_study_id