Myocardial Ischemia Clinical Trial
Official title:
Local-Tax Trial: Local Intracoronary Administration of Paclitaxel After Stent Implantation for Prevention of Restenosis in Comparison With Stent Implantation Alone and With Implantation of a Paclitaxel-Eluting Stent
The aim of the study is to examine the efficacy of Paclitaxel injection after a stent implantation in patients with stenosis in native coronary arteries to prevent restenosis in comparision with two admitted therapies.
Status | Active, not recruiting |
Enrollment | 204 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - age: 18 to 80, males or females - stable or instable angina pectoris and or/ documented myocardial ischemia - willingness and ability to adhere to the study conditions - written informed consent after patient information - De-novo stenosis of coronary artery with a degree of stenosis between 50% and 99%, that is accessible to PTCA - Target vessels diameter of at least 2,5 mm and length of lesion below 18 mm 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 - intracardiac 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 - significant upper intestinal bleeding within the last 6 months - life expectancy < 1 year - poor general condition - Premenopausal women, women who are postmenopausal less than 2 years - known allergy or hypersensitivity to Paclitaxel, to one of the TAXOL-components, to one of the stent components, to acetylsalicylic acid, heparin, clopidogrel 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 - absence of written declaration of consent - inability, to understand sense and purpose of the study or not willing to keep the conditions of the study - Bifurcation stenosis, ostium stenosis, main stem stenosis ot the target vessel - visible thrombus in target vessel - Severely curved or sclerosed 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Abteilung Kardiologie und Kreislauferkrankungen, Medizinische Universitätsklinik und Poliklinik III, Universitätsklinikum Tübingen | Tuebingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen | Acrostak |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective is the angiographical determination of the late lumen loss in the stent and/or persistent area, 6 month after stent implantation. | week 26 +/- 14 days | ||
Secondary | The angiographical determination of the binary restenosis rate, defined as diameter stenosis of at least 50 % in the stent and / or persistent area, 6 months after stent implantation. | week 26 +/- 14 days | ||
Secondary | The angiographical determination of the degree of stenosis, defined as percentage diameter stenosis in the stent and /or persistent area, 6 months after stent implantation. | week 26, +/- 14 days | ||
Secondary | Tthe angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation. | week 26, +/- 14 days | ||
Secondary | 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. | week 26, +/-14 days |
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