coronary heart disease
Conditions
Interventions
Trade Name: TAXOL
Product Name: not applicable
Product Code: not applicable
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: paclitaxel
Concentration unit: mg/ml milligr
Sponsors
University Hospital Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age: 18-80 years, gender: male and female - Stable or unstable angina pectoris and / or documented myocardial ischemia - Ability and willingness to adhere to the study conditions - Written informed consent - De-novo stenosis of coronary artery with a degree of stenosis between 50% and 99%, that is accessible to PTCA - Target vesses diameter of at least 2,5 mm and length of lesion below 18 mm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Acute myocardial infarction or still elevated CK/CK-MB after acute myocardial infarction - Known severe arrhythmias that necessitate a long term antiarrhythmic therapy - Pericarditis - Intracardial thrombus - Bacterial endocarditis - Cardiopulmonary reanimation with cardiac massage within the last 6 months - Thromboembolic accident within the last 6 months - Severe peripheral arterial occlusive disease, that excludes the use of a 6 French catheter or that requires a special antithrombotic or anticoagulatory regime - Manifest hyperthyreosis - Neutrohile granulocytes less than 3000/mm3 and platelets below 100.000 or above 700.000/mm3 - Renal insufficiency with serum creatinine above 1,5 mg/L - Severe systemic hypertension despite antihypertensive medication - Other diseases which might lead to protocol violations or reduce life expectancy - Life expectancy below 1 year - Poor general condition - Premenopausal women, women who are postmeopausal less than 2 years - Known allergy or hypersensitivity to one of the components of TAXOL®, to one of the stent components, to ASS, clopidogrel, heparin or contrast agent - Concurrent participation or participation within the last 30 days prior to screening in another drug trial or a trial with a medical device - Bifurcation stenosis, ostium stenosis, main stem stenosis of the target vessel - Severly curved or sclerosed target vessel - Visible thrombus in target vessel - Complete closure of target vessel - Severe impairment of left ventricular function with left ventricular ejection fraction of less than 30% - Patients with expected indication for operative myocardial revascularisation within the next six months - Patients with contraindication for aortocoronary bypass operation - Patients who are principally not available for a second coronary angiography 6 months after stent implantation or who have a contraindication for a second coronary angiography
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of this clinical trial is to examine whether in patients with stable or unstable angina pectoris and / or documented myocardial ischemia in the presence of de-novo stenoses in native coronary arteries with a degree of stenosis between 50% and 99% an additional local administration of paclitaxel after implantation of a conventional stent is superior to the implantation of a conventional stent alone with respect to late lumen loss. In case of superiority it will be examined whether an additional local administration of paclitaxel after implantation of a conventional stent is not inferior to the implantation of a paclitaxel-eluting stent with respect to late lumen loss. Is this the case, superiority will be tested. ;Secondary Objective: 1)A secondary objective of this clinical trial is the angiographical determination of the binary restenosis rate, defined as diameter stenosis of at least 50% in the stent and / or peristent area, 6 months after stent implantation. 2)A secondary objective of this clinical trial is the angiographical determination of the degree of stenosis, defined as percentage diameter stenosis in the stent and / or peristent area, 6 months after stent implantation. 3)A secondary objective of this clinical trial is the angiographical determination of the minimal lumen diameter in the stent and / or peristent area, 6 months after stent implantation. 4)A secondary objective of this clinical trial is the 6 months after stent implantation determined combined endpoint of abrupt and subabrupt closure of the target vessel, target lesion revascularisation and major adverse cardiac events including myocardial infarction and death. ;Primary end point(s): The primary objective of this clinical trial is the angiographical determination of the late lumen loss in the stent and / or peristent area, 6 months after stent implantation. | — |
Countries
Germany
Outcome results
None listed