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Austrian Multivessel Taxus-Stent Registry

NCT ID: NCT00738686

Last Updated: 2008-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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coronary artery disease drug-eluting stent percutaneous coronary intervention major adverse cardiac event in-stent restenosis stent thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Single-arm study, no placebo or control group

Group Type EXPERIMENTAL

Intracoronary stent implantation

Intervention Type DEVICE

Taxus stent implantation in patients with multivessel coronary artery disease

Interventions

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Intracoronary stent implantation

Taxus stent implantation in patients with multivessel coronary artery disease

Intervention Type DEVICE

Other Intervention Names

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Taxus Express Taxus Liberte

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Dept. Cardiology, Medical University of Vienna, Austria

Principal Investigators

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Helmut-Dietmar Glogar, MD FESC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Landeskrankenhaus

Bruck an der Mur, , Austria

Site Status

Department of Interventional Cardiology, Academic Hospital

Feldkirch, , Austria

Site Status

Landeskrankenhaus Graz-West

Graz, , Austria

Site Status

Allgemeines Krankenhaus der Stadt Linz

Linz, , Austria

Site Status

Krankenhaus Barmherzigen Schwestern

Linz, , Austria

Site Status

St. Johannes Spital

Salzburg, , Austria

Site Status

Rudolfstiftung

Vienna, , Austria

Site Status

Countries

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Austria

References

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Gyongyosi M, Christ G, Lang I, Kreiner G, Sochor H, Probst P, Neunteufl T, Badr-Eslam R, Winkler S, Nyolczas N, Posa A, Leisch F, Karnik R, Siostrzonek P, Harb S, Heigert M, Zenker G, Benzer W, Bonner G, Kaider A, Glogar D; AUTAX Investigators. 2-year results of the AUTAX (Austrian Multivessel TAXUS-Stent) registry beyond the SYNTAX (synergy between percutaneous coronary intervention with TAXUS and cardiac surgery) study. JACC Cardiovasc Interv. 2009 Aug;2(8):718-27. doi: 10.1016/j.jcin.2009.05.019.

Reference Type DERIVED
PMID: 19695539 (View on PubMed)

Other Identifiers

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AUTAX

Identifier Type: -

Identifier Source: org_study_id