NCT00485004CompletedPhase 4
FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent
Seung-Jung Park29 sites in 2 countries100 target enrollmentStarted: March 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 29
- Primary Endpoint
- Binary In-segment Restenosis
Study Overview
Brief Summary
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
Detailed Description
Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient must be at least 18 years of age.
- •Restenosis after drug-eluting stents (>50% by visual estimate)
- •Lesion length < 10 mm (focal ISR)
- •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
- •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
- •The patient has a known hypersensitivity or contraindication to any of the following medications:
- •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).
- •Systemic (intravenous) Sirolimus use within 12 months.
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- •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).
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Patients with EF<30%.
- •Acute MI patients within symptom onset < 12 hours needing primary angioplasty
- •Creatinine level 3.0mg/dL or dependence on dialysis.
- •Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
- •Patients with left main stem stenosis and left main in-stent restenosis created by DES(>50% by visual estimate)
Arms & Interventions
Cutting balloon
Experimental
Cutting balloon
Intervention: Cutting balloon (Device)
Cutting balloon
Experimental
Cutting balloon
Intervention: Sirolimus-eluting stent (Device)
Sirolimus-eluting stent
Active Comparator
Sirolimus-eluting stent
Intervention: Cutting balloon (Device)
Sirolimus-eluting stent
Active Comparator
Sirolimus-eluting stent
Intervention: Sirolimus-eluting stent (Device)
Outcomes
Primary Outcomes
Binary In-segment Restenosis
Time Frame: At 9 months angiographic follow-up
Secondary Outcomes
- Composite end-point of death, myocardial infarction, or target vessel revascularization(At 9-month after index procedure)
- Stent thrombosis(In-hospital, 30 days, 9 months, and 1year)
- Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion(during the hospital stay)
- Late luminal loss(at 8 month angiographic follow-up)
Investigators
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea
Study Sites (29)
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