Austrian Multivessel Taxus-Stent Registry

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Intracoronary stent implantation

• Registration Number: NCT00738686
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Last Update Submitted: 2008-08-20
• Last Update Posted: 2008-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Intracoronary stent implantation	Single-arm study, no placebo or control group

Primary Outcome Measures

Name	Time	Method
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)	2 year

Secondary Outcome Measures

Name	Time	Method
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	2 year
Incidence of 30-days, 6-mo and 1-year MACCE	1 year
Acute, subacute and late thrombosis rates	2 year
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	6-month

Trial Locations

Locations (7)

Landeskrankenhaus; 🇦🇹 Bruck an der Mur, Austria

Rudolfstiftung; 🇦🇹 Vienna, Austria

Landeskrankenhaus Graz-West; 🇦🇹 Graz, Austria

Krankenhaus Barmherzigen Schwestern; 🇦🇹 Linz, Austria

Department of Interventional Cardiology, Academic Hospital; 🇦🇹 Feldkirch, Austria

St. Johannes Spital; 🇦🇹 Salzburg, Austria

Allgemeines Krankenhaus der Stadt Linz; 🇦🇹 Linz, Austria