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

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

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

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.

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

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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