- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00396929
Efficiency of a New Therapy to Treat Stenosis of Coronary Vessels in Comparison With Two Already Admitted Therapies
May 15, 2007 updated by: University Hospital Tuebingen
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
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
204
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tuebingen, Germany, 72076
- Abteilung Kardiologie und Kreislauferkrankungen, Medizinische Universitätsklinik und Poliklinik III, Universitätsklinikum Tübingen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
week 26 +/- 14 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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
|
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
|
week 26, +/-14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Christian Herdeg, PD, Universitätsklinikum Tübingen, Medizinische Universitäts und Poliklinik III, Abteilung Kardiologie und Kreislauferkrankungen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Study Completion (Anticipated)
July 1, 2007
Study Registration Dates
First Submitted
November 7, 2006
First Submitted That Met QC Criteria
November 7, 2006
First Posted (Estimate)
November 8, 2006
Study Record Updates
Last Update Posted (Estimate)
May 16, 2007
Last Update Submitted That Met QC Criteria
May 15, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Chest Pain
- Myocardial Ischemia
- Ischemia
- Angina Pectoris
- Angina, Unstable
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- TAX-001
- 2005-001481-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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