Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™
Phase 3
Terminated
- Conditions
- Coronary De-novo Stenoses
- Interventions
- Device: SeQuent®Please (Paclitaxel coated balloon)Device: Taxus™Liberté™ (Paclitaxel eluting stent)
- Registration Number
- NCT01084408
- Lead Sponsor
- University Hospital, Saarland
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 90
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequent®Please SeQuent®Please (Paclitaxel coated balloon) - Taxus™Liberté™ Taxus™Liberté™ (Paclitaxel eluting stent) -
- Primary Outcome Measures
Name Time Method Late lumen loss 6 months Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.
- Secondary Outcome Measures
Name Time Method 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) 30 days, 6, 12, 24, 60 months consisting of thrombotic occlusion of the treated segment, target lesion revascularization, myocardial infarction, or death
Trial Locations
- Locations (2)
Klinik für Kardiologie, Angiologie und Konservative Intensivtherapie Klinikum Ernst von Bergmann
🇩🇪Postdam, Brandenburg, Germany
Medizinisches Versorgungszentrum
🇩🇪Hamburg, Germany