Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™

Study Overview
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Brief Summary
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The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.

Official Title
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Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon

Conditions
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Coronary De-novo Stenoses

Intervention / Treatment
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* Device: SeQuent®Please (Paclitaxel coated balloon)
* Device: Taxus™Liberté™ (Paclitaxel eluting stent)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Clinical evidence of stable or unstable angina or a positive functional study Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types) Diameter stenosis > 70% (visual estimate) Vessel diameter 2.5 - 3.5 mm Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization Signed patient informed consent form Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol Exclusion Criteria: Left ventricular ejection fraction of < 30% Visible thrombus proximal to the lesion Expection that treatment with devices other than PTCA will be required for this lesion. Stenosis is within a bypass graft Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years). Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) >3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment) Chronic renal insufficiency with serum creatinine > 2.0 mg% Significant gastrointestinal (GI) bleed within the past six months. History of bleeding diathesis or coagulopathy or will refuse blood transfusions Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment. Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Active Comparator: Sequent®Please<br> | Device: SeQuent®Please (Paclitaxel coated balloon)<br>* PCI of de-novo lesions<br>|
| Active Comparator: Taxus™Liberté™<br> | Device: Taxus™Liberté™ (Paclitaxel eluting stent)<br>* PCI of de-novo lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss | Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombotic occlusion of the target lesion |  | 30 days, 6, 12, 24, 60 months | 
| Revascularization of the target lesion |  | 30 days, 6, 12, 24, 60 months | 
| Myocardial infarction |  | 30 days, 6, 12, 24, 60 months | 
| Death |  | 30 days, 6, 12, 24, 60 months | 
| Combined clinical endpoint (MACE) | consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death | 30 days, 6, 12, 24, 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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de-novo, coronary stenoses, PEPCAD, DEBonly, Paclitaxel