search
Back to results

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

Primary Purpose

Stable or Unstable Angina Pectoris, Myocardial Ischemia

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
local intracoronary dosis of Paclitaxel
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable or Unstable Angina Pectoris focused on measuring Paclitaxel, Restenosis, Stent, Intracoronary Dosis, Paclitaxel-eluting Stent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

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.

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.
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.
Tthe angiographical determination of the minimal lumen diameter in the stent and / or persistent area, 6 months after stent implantation.
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.

Full Information

First Posted
November 7, 2006
Last Updated
May 15, 2007
Sponsor
University Hospital Tuebingen
Collaborators
Acrostak
search

1. Study Identification

Unique Protocol Identification Number
NCT00396929
Brief Title
Efficiency of a New Therapy to Treat Stenosis of Coronary Vessels in Comparison With Two Already Admitted Therapies
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital Tuebingen
Collaborators
Acrostak

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable or Unstable Angina Pectoris, Myocardial Ischemia
Keywords
Paclitaxel, Restenosis, Stent, Intracoronary Dosis, Paclitaxel-eluting Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
local intracoronary dosis of Paclitaxel
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Herdeg, PD
Organizational Affiliation
Universitätsklinikum Tübingen, Medizinische Universitäts und Poliklinik III, Abteilung Kardiologie und Kreislauferkrankungen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abteilung Kardiologie und Kreislauferkrankungen, Medizinische Universitätsklinik und Poliklinik III, Universitätsklinikum Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
20031731
Citation
Herdeg C, Gohring-Frischholz K, Haase KK, Geisler T, Zurn C, Hartmann U, Wohrle J, Nusser T, Dippon J, May AE, Gawaz M. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs