Austrian Multivessel Taxus-Stent Registry (AUTAX)

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Intracoronary stent implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00738686

AUTAX

Details and patient eligibility

About

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.

Enrollment: 441 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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441 participants in 1 patient group

1

Experimental group

Description:

Single-arm study, no placebo or control group

Treatment:

Device: Intracoronary stent implantation