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

Phase 3

• Conditions: Stable or Unstable Angina Pectoris; Myocardial Ischemia

• Registration Number: NCT00396929
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2006-11-07
• Study First Submitted QC: 2006-11-07
• Study First Posted: 2006-11-08
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-15
• Last Update Posted: 2007-05-16
• Study Completion: 2007-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Abteilung Kardiologie und Kreislauferkrankungen, Medizinische Universitätsklinik und Poliklinik III, Universitätsklinikum Tübingen; 🇩🇪 Tuebingen, Germany