Austrian Multivessel Taxus-Stent Registry

NCT00738686 | Completed Phase 4 DMC

• 1 other identifier: AUTAX
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 7

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. 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. 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. 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. 4.To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

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)

  2 year

Secondary Outcomes (4)

• 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

Study Arms (1)

1

EXPERIMENTAL

Single-arm study, no placebo or control group

Device: Intracoronary stent implantation

Interventions

Intracoronary stent implantation DEVICE

Taxus stent implantation in patients with multivessel coronary artery disease

Also known as: Taxus Express, Taxus Liberte

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic coronary multivessel disease
• possible percutaneous complete coronary revascularization
• age \>18 year
• significant coronary lesion at least in 2 vessels

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (7)

Landeskrankenhaus

Bruck an der Mur, Austria

Location

Department of Interventional Cardiology, Academic Hospital

Feldkirch, Austria

Location

Landeskrankenhaus Graz-West

Graz, Austria

Location

Allgemeines Krankenhaus der Stadt Linz

Linz, Austria

Location

Krankenhaus Barmherzigen Schwestern

Linz, Austria

Location

St. Johannes Spital

Salzburg, Austria

Location

Rudolfstiftung

Vienna, Austria

Location

Related Publications (1)

• 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.

  PMID: 19695539 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Helmut-Dietmar Glogar, MD FESC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2008
• First Posted: August 20, 2008
• Study Start: June 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 21, 2008

Record last verified: 2008-08

Locations

AU (7)