Austrian Multivessel Taxus-Stent Registry - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00738686

Purpose

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	Intervention	Phase
Coronary Artery Disease	Device: Intracoronary stent implantation	Phase IV

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Austrian Multivessel Taxus-Stent Registry

Further study details as provided by Medical University of Vienna:

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) [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
Incidence of 30-days, 6-mo and 1-year MACCE [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Acute, subacute and late thrombosis rates [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Enrollment:	441
Study Start Date:	June 2004
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Single-arm study, no placebo or control group	Device: Intracoronary stent implantation Taxus stent implantation in patients with multivessel coronary artery disease

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738686

Locations

Austria
Allgemeines Krankenhaus der Stadt Linz
Linz, Austria
Rudolfstiftung
Vienna, Austria
Krankenhaus Barmherzigen Schwestern
Linz, Austria
Department of Interventional Cardiology, Academic Hospital
Feldkirch, Austria
St. Johannes Spital
Salzburg, Austria
Landeskrankenhaus
Bruck an der Mur, Austria
Landeskrankenhaus Graz-West
Graz, Austria

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Helmut-Dietmar Glogar, MD FESC

Dept. Cardiology, Medical University of Vienna, Vienna, Austria

More Information

Responsible Party:	Dept. Cardiology, Medical University of Vienna, Austria ( Helmut-Dietmar Glogar )
Study ID Numbers:	AUTAX
Study First Received:	August 19, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00738686
Health Authority:	Austria: Ethikkommission

Keywords provided by Medical University of Vienna:

coronary artery disease
drug-eluting stent
percutaneous coronary intervention

major adverse cardiac event
in-stent restenosis
stent thrombosis

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Arteriosclerosis
Ischemia
Thrombosis
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009