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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stable or Unstable Angina Pectoris
- Sponsor
- University Hospital Tuebingen
- Enrollment
- 204
- Locations
- 1
- Primary Endpoint
- The primary objective is the angiographical determination of the late lumen loss in the stent and/or persistent area, 6 month after stent implantation.
- Last Updated
- 18 years ago
Overview
Brief Summary
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.
Detailed Description
The aim of the study is to examine whether in patients with stable or instable Angina pectoris and/or documented myocardial ischemia in the presence of de-novo stenosis 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 (LLL). 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-luss. Is this the case, superiority will be tested.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The primary objective is the angiographical determination of the late lumen loss in the stent and/or persistent area, 6 month after stent implantation.
Time Frame: week 26 +/- 14 days
Secondary Outcomes
- 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)
- 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)
- Tthe angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation.(week 26, +/- 14 days)
- 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)