Coronary De-novo Stenoses
Conditions
Keywords
de-novo, coronary stenoses, PEPCAD, DEBonly, Paclitaxel
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.
Interventions
DEVICESeQuent®Please (Paclitaxel coated balloon)
PCI of de-novo lesions
DEVICETaxus™Liberté™ (Paclitaxel eluting stent)
PCI of de-novo lesions
Sponsors
University Hospital, Saarland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed