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

• Status: Unknown status
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Collaborator: Acrostak
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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

• 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