Austrian Multivessel Taxus-Stent Registry

Coronary Artery Disease Clinical Trial

— AUTAX  

Official title:

Austrian Multivessel Taxus-Stent Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738686
• Other study ID #: AUTAX
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2008
• Last updated: August 20, 2008
• Start date: June 2004
• Est. completion date: May 2008

Study information

• Verified date: August 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Intracoronary stent implantation
Taxus stent implantation in patients with multivessel coronary artery disease

Locations

Country	Name	City	State
Austria	Landeskrankenhaus	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	Rudolfstiftung	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	Incidence of 30-days, 6-mo and 1-year MACCE		1 year	Yes
Secondary	Acute, subacute and late thrombosis rates		2 year	Yes
Secondary	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	No