Austrian Multivessel Taxus-Stent Registry (AUTAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00738686
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : August 21, 2008
Information provided by:
Medical University of Vienna

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:

  1. 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..
  2. 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.
  3. 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.
  4. 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Austrian Multivessel Taxus-Stent Registry
Study Start Date : June 2004
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Single-arm study, no placebo or control group
Device: Intracoronary stent implantation
Taxus stent implantation in patients with multivessel coronary artery disease
Other Names:
  • Taxus Express
  • Taxus Liberte

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Incidence of 30-days, 6-mo and 1-year MACCE [ Time Frame: 1 year ]
  3. Acute, subacute and late thrombosis rates [ Time Frame: 2 year ]
  4. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00738686

Bruck an der Mur, Austria
Department of Interventional Cardiology, Academic Hospital
Feldkirch, Austria
Landeskrankenhaus Graz-West
Graz, Austria
Allgemeines Krankenhaus der Stadt Linz
Linz, Austria
Krankenhaus Barmherzigen Schwestern
Linz, Austria
St. Johannes Spital
Salzburg, Austria
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Helmut-Dietmar Glogar, MD FESC Dept. Cardiology, Medical University of Vienna, Vienna, Austria

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Helmut-Dietmar Glogar, Dept. Cardiology, Medical University of Vienna, Austria Identifier: NCT00738686     History of Changes
Other Study ID Numbers: AUTAX
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases