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

Sponsors and Collaborators:	University Hospital Tuebingen Acrostak
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00396929

Purpose

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.

Condition	Intervention	Phase
Stable or Unstable Angina Pectoris Myocardial Ischemia	Drug: local intracoronary dosis of Paclitaxel	Phase III

MedlinePlus related topics: Angina

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

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 Outcome Measures:

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. [ Time Frame: 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. [ Time Frame: week 26, +/- 14 days ]
Tthe angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation. [ Time Frame: 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. [ Time Frame: week 26, +/-14 days ]

Estimated Enrollment:	204
Study Start Date:	August 2005
Estimated Study Completion Date:	July 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396929

Locations

Germany
Abteilung Kardiologie und Kreislauferkrankungen, Medizinische Universitätsklinik und Poliklinik III, Universitätsklinikum Tübingen
Tuebingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Acrostak

Investigators

Principal Investigator:

Christian Herdeg, PD

Universitätsklinikum Tübingen, Medizinische Universitäts und Poliklinik III, Abteilung Kardiologie und Kreislauferkrankungen

More Information

Study ID Numbers:	TAX-001, 2005-001481-14
Study First Received:	November 7, 2006
Last Updated:	May 15, 2007
ClinicalTrials.gov Identifier:	NCT00396929
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

Paclitaxel
Restenosis
Stent
Intracoronary Dosis
Paclitaxel-eluting Stent

Study placed in the following topic categories:

Signs and Symptoms
Heart Diseases
Paclitaxel
Myocardial Ischemia
Vascular Diseases
Angina Pectoris

Pain
Constriction, Pathologic
Ischemia
Angina, Unstable
Chest Pain

Additional relevant MeSH terms:

Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Cardiovascular Diseases
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009