Focal In-stent Restenosis After Drug-Eluting Stent

Study Overview
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Brief Summary
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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
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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.

Official Title
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FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent

Conditions
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In Stent Restenosis

Intervention / Treatment
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* Device: Cutting balloon
* Device: Sirolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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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: 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). 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cutting balloon<br>Cutting balloon | Device: Cutting balloon<br>* Cutting balloon<br>Device: Sirolimus-eluting stent<br>* Sirolimus-eluting stent<br>|
| Active Comparator: Sirolimus-eluting stent<br>Sirolimus-eluting stent | Device: Cutting balloon<br>* Cutting balloon<br>Device: Sirolimus-eluting stent<br>* Sirolimus-eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary In-segment Restenosis |  | At 9 months angiographic follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Late luminal loss |  | at 8 month angiographic follow-up | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, Stent, Angioplasty