Austrian Multivessel Taxus-Stent Registry (AUTAX)
|ClinicalTrials.gov Identifier: NCT00738686|
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : August 21, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: Intracoronary stent implantation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||441 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Austrian Multivessel Taxus-Stent Registry|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
Single-arm study, no placebo or control group
Device: Intracoronary stent implantation
Taxus stent implantation in patients with multivessel coronary artery disease
- 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 ]
- 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 ]
- Incidence of 30-days, 6-mo and 1-year MACCE [ Time Frame: 1 year ]
- Acute, subacute and late thrombosis rates [ Time Frame: 2 year ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738686
|Bruck an der Mur, Austria|
|Department of Interventional Cardiology, Academic Hospital|
|Allgemeines Krankenhaus der Stadt Linz|
|Krankenhaus Barmherzigen Schwestern|
|St. Johannes Spital|
|Principal Investigator:||Helmut-Dietmar Glogar, MD FESC||Dept. Cardiology, Medical University of Vienna, Vienna, Austria|