Efficiency of a New Therapy to Treat Stenosis of Coronary Vessels in Comparison With Two Already Admitted Therapies

University Hospital Tuebingen

Status and phase

Unknown

Phase 3

Conditions

Stable or Unstable Angina Pectoris

Myocardial Ischemia

Treatments

Drug: local intracoronary dosis of Paclitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00396929

2005-001481-14

TAX-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

204 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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