International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.

Official Title
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International Randomized Comparison Between DES Limus Carbostent and Taxus Drug Eluting Stents in the Treatment of De-novo Coronary Lesions. The NEXT Study.

Conditions
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Stable Angina, Unstable Angina, Documented Silent Ischemia

Intervention / Treatment
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* Device: DES Limus Carbostent
* Device: Taxus Liberté Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Patient is eligible for percutaneous coronary intervention (PCI) and for surgical revascularization (CABG) Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site Patients with clinical evidence of ischemic heart disease and/or a positive functional study(e.g. stress test); documented stable (CCS I-IV) or unstable angina pectoris (Braunwald class I-II B and C) or documented silent ischemia LVEF>30% Requires treatment of a single de novo lesion in a native coronary artery in one or two different major epicardial vessels (LAD, LCX or RCA). The second lesion must fit with inclusion/exclusion criteria and must be treated with the same study stent as the first lesion Target lesion should be located in a target vessel with a diameter ranging from 3.0 to 3.75 mm Target lesion diameter stenosis > 50% and < 100% by visual estimate, with a TIMI flow of ≥ 1 The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm). Any occurred dissection of the target vessel must be treated with an additional stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm) Patient that underwent BMS implantation more than 6 months before the enrolment or DES implantation more than 1 year before the enrolment in an other vessel. Exclusion Criteria: Female with childbearing potential or lactating Known sensitivity to sirolimus, paclitaxel, the polymeric matrix, stainless steel or cobalt chromium Acute Q-wave or non Q-wave myocardial infarction within 72 hours, or presents with CK elevation greater than 2 times upper limit normal associated with elevated CK-MB Cardiogenic shock Cerebrovascular accident within the past 6 months Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl) Contraindication to aspirin or clopidogrel Thrombocytopenia (platelet count less than 100,000/mm³) Active gastrointestinal bleeding within the past 3 months Known bleeding or hypercoagulable disorder Prior anaphylactic reaction to contrast agents or contrast sensitivity that cannot be controlled with pre-medication Currently under immunosuppressant therapy Currently, or has been treated with either Rapamune or paclitaxel within 12 months of the procedure Active infection Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year; Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study Patient underwent coronary revascularization to any vessel within 30 days Patient underwent target vessel revascularization within 6 months Target vessel has had prior stent placement Presence of two lesions located in the same vascular territory (same major epicardial vessel) Prior coronary brachytherapy There is a planned target lesion treatment with any technique other than the pre-dilatation balloon angioplasty Treatment of more than two lesions is required at the time of enrolment, or is planned within 30 days following enrolment Any planned surgery within 6 months after index procedure Left main disease greater than 50% diameter stenosis Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off Heavily calcified vessel and/or lesion which cannot be successfully predilated Target lesion is located or supplied by an arterial or venous bypass graft Ostial target lesion or lesion located within 2 mm of a bifurcation Target lesion involves a side branch >2.0 mm in diameter with an ostial disease Target lesion has TIMI 0 flow Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.

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: DES Limus Carbostent Coronary Stent<br> | Device: DES Limus Carbostent<br>* DES Limus Carbostent Carbofilm Coated Coronary Stent<br>|
| Active Comparator: Taxus Liberté Coronary Stent<br> | Device: Taxus Liberté Stent<br>* Taxus Liberté Coronary Stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic efficacy measurement (mm) | in-stent Late Lumen Loss (LLL) measurement by angiography | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QCA measurements in-stent and in-segment |  | 180 days | 
| IVUS measurements |  | 180 days | 
| Incidence of cardiac death (%) |  | 30 days, 180 days, 1, 2 , 3, 4 and 5 years | 
| Stent Thrombosis |  | acute, 30 days, 180 days, 1 year, > 1 year | 
| Acute success (Device and Procedural success) |  | acute | 
| Incidence of Myocardial Infarction (%) |  | 30 days, 180 days, 1, 2, 3, 4, 5 years | 
| Incidence of clinically indicated TLR (%) |  | 30 days, 180 days, 1, 2, 3, 4, 5 years | 
| Incidence of all deaths (%) |  | 30 days, 180 days, 1, 2, 3, 4, 5 years | 
| Incidence of all repeat revascularization (%) |  | 30 days, 180 days, 1, 2, 3, 4, 5 years |