Austrian Multivessel Taxus-Stent Registry (AUTAX)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Intracoronary stent implantation
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, drug-eluting stent, percutaneous coronary intervention, major adverse cardiac event, in-stent restenosis, stent thrombosis
Eligibility Criteria
Inclusion Criteria:
- symptomatic coronary multivessel disease
- possible percutaneous complete coronary revascularization
- age >18 year
- significant coronary lesion at least in 2 vessels
Exclusion Criteria:
- acute myocardial infarction within 48 hours
- contraindications to clopidogrel, aspirin, heparin and taxol
- pregnancy or lack of protection against pregnancy or breast-feeding during the study
- hemorrhagic diathesis
- platelet count <100.000/ml3
Sites / Locations
- Landeskrankenhaus
- Department of Interventional Cardiology, Academic Hospital
- Landeskrankenhaus Graz-West
- Allgemeines Krankenhaus der Stadt Linz
- Krankenhaus Barmherzigen Schwestern
- St. Johannes Spital
- Rudolfstiftung
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Single-arm study, no placebo or control group
Outcomes
Primary Outcome Measures
Incidence of MACCE, defined as all-cause death, nonfatal acute myocardial infarction (AMI) target vessel revascularization (TVR) and cerebrovascular event during the two-year clinical follow-up (FUP)
Secondary Outcome Measures
Break-down primary endpoints at the 2-year FUP, as the rate of TVR, non-fatal AMI, all-cause death, stroke and the composite of death and AMI
Incidence of 30-days, 6-mo and 1-year MACCE
Acute, subacute and late thrombosis rates
Angiographic end-points as the binary restenosis rate per lesion (defined as diameters stenosis ≥ 50%), in-stent and proximal and distal in-lesion late lumen loss
Full Information
NCT ID
NCT00738686
First Posted
August 19, 2008
Last Updated
August 20, 2008
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00738686
Brief Title
Austrian Multivessel Taxus-Stent Registry
Acronym
AUTAX
Official Title
Austrian Multivessel Taxus-Stent Registry
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of AUTAX study is to investigate the frequency of MACCE in patients with multivessel disease and multiple Taxus stent implantations in the "real world" stenting at 30 days, 6 and 12 months at 2 year follow-up. Because multivessel stenting using DES has been limited due to economic considerations, the secondary aim is to enhance experience in multivessel stenting with drug-eluting stents in order to improve short- and long-term outcomes of the patients with severe multiple coronary artery stenoses.
The objectives of the study are:
To determine the frequency of MACCE at 30-day, 6 and 12-month and at 2 year clinical follow-up after multivessel intervention with drug-eluting stents in a prospective patient cohort..
To determine the rate of in-stent restenosis, target lesion and target vessel revascularization (angiographic measures) 6 months in patients with multiple DESs in multiple lesions.
To investigate the clinical and angiographic outcomes after implantation of multiple DESs in the subgroup of patients with accompanying diseases (diabetes mellitus, renal insufficiency) with known high restenosis and late complication rate.
To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, drug-eluting stent, percutaneous coronary intervention, major adverse cardiac event, in-stent restenosis, stent thrombosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
441 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Single-arm study, no placebo or control group
Intervention Type
Device
Intervention Name(s)
Intracoronary stent implantation
Other Intervention Name(s)
Taxus Express, Taxus Liberte
Intervention Description
Taxus stent implantation in patients with multivessel coronary artery disease
Primary Outcome Measure Information:
Title
Incidence of MACCE, defined as all-cause death, nonfatal acute myocardial infarction (AMI) target vessel revascularization (TVR) and cerebrovascular event during the two-year clinical follow-up (FUP)
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Break-down primary endpoints at the 2-year FUP, as the rate of TVR, non-fatal AMI, all-cause death, stroke and the composite of death and AMI
Time Frame
2 year
Title
Incidence of 30-days, 6-mo and 1-year MACCE
Time Frame
1 year
Title
Acute, subacute and late thrombosis rates
Time Frame
2 year
Title
Angiographic end-points as the binary restenosis rate per lesion (defined as diameters stenosis ≥ 50%), in-stent and proximal and distal in-lesion late lumen loss
Time Frame
6-month
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:
symptomatic coronary multivessel disease
possible percutaneous complete coronary revascularization
age >18 year
significant coronary lesion at least in 2 vessels
Exclusion Criteria:
acute myocardial infarction within 48 hours
contraindications to clopidogrel, aspirin, heparin and taxol
pregnancy or lack of protection against pregnancy or breast-feeding during the study
hemorrhagic diathesis
platelet count <100.000/ml3
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut-Dietmar Glogar, MD FESC
Organizational Affiliation
Dept. Cardiology, Medical University of Vienna, Vienna, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landeskrankenhaus
City
Bruck an der Mur
Country
Austria
Facility Name
Department of Interventional Cardiology, Academic Hospital
City
Feldkirch
Country
Austria
Facility Name
Landeskrankenhaus Graz-West
City
Graz
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Linz
City
Linz
Country
Austria
Facility Name
Krankenhaus Barmherzigen Schwestern
City
Linz
Country
Austria
Facility Name
St. Johannes Spital
City
Salzburg
Country
Austria
Facility Name
Rudolfstiftung
City
Vienna
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
19695539
Citation
Gyongyosi M, Christ G, Lang I, Kreiner G, Sochor H, Probst P, Neunteufl T, Badr-Eslam R, Winkler S, Nyolczas N, Posa A, Leisch F, Karnik R, Siostrzonek P, Harb S, Heigert M, Zenker G, Benzer W, Bonner G, Kaider A, Glogar D; AUTAX Investigators. 2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study. JACC Cardiovasc Interv. 2009 Aug;2(8):718-27. doi: 10.1016/j.jcin.2009.05.019.
Results Reference
derived
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Austrian Multivessel Taxus-Stent Registry
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