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Completed

NCT Number: NCT00738686

Austrian Multivessel Taxus-Stent Registry

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Landeskrankenhaus, Bruck an der Mur, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intracoronary stent implantation

Device

Taxus stent implantation in patients with multivessel coronary artery disease

Other names: Taxus Express, Taxus Liberte

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: AUTAX

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Aug 20, 2008
Registry last updated
Aug 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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