Coronary Artery DiseasePhase 4AUTAXNCT00738686
Austrian Multivessel Taxus-Stent Registry
A Phase 4 study testing Intracoronary stent implantation in people with Coronary Artery Disease, run by Medical University of Vienna at 7 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intracoronary stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 7 sitesAustria
- Study dates
- Jun 2004to May 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic coronary multivessel disease
- possible percutaneous complete coronary revascularization
- age >18 year
- significant coronary lesion at least in 2 vessels
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
Austria7 sites
Landeskrankenhaus
Bruck an der Mur
Department of Interventional Cardiology, Academic Hospital
Feldkirch
Landeskrankenhaus Graz-West
Graz
Allgemeines Krankenhaus der Stadt Linz
Linz
Krankenhaus Barmherzigen Schwestern
Linz
St. Johannes Spital
Salzburg
Rudolfstiftung
Vienna
About this study
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:
- 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..
- 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.
- 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.
- To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.
- Conditions
- Coronary Artery Disease
- Being tested
- Intracoronary stent implantation
- Keywords
- coronary artery disease, drug-eluting stent, percutaneous coronary intervention, major adverse cardiac event, in-stent restenosis, stent thrombosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary stent implantationDevice
Also called Taxus Express, Taxus Liberte
Taxus stent implantation in patients with multivessel coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single-arm study, no placebo or control group Receives: Device: Intracoronary stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 2 year
Incidence of 30-days, 6-mo and 1-year MACCE
Measured: 1 year
Acute, subacute and late thrombosis rates
Measured: 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
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJun 2004
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Helmut-Dietmar Glogar, MD FESC, Principal investigator, Dept. Cardiology, Medical University of Vienna, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738686
- Sponsor's protocol ID
- AUTAX
- Acronym
- AUTAX
- Status last verified
- Aug 2008
- First submitted
- 19 Aug 2008
- Last updated
- 21 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19695539
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Austrian Multivessel Taxus-Stent Registry
- ClinicalTrials.gov ID
- NCT00738686
- Acronym / sponsor ID
- AUTAX / AUTAX
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, drug-eluting stent, percutaneous coronary intervention, major adverse cardiac event, in-stent restenosis, stent thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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..
- 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.
- 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.
- To evaluate potential cost burden in attempting a strategy of complete revascularization by multiple DES in patients with multivessel disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Intracoronary stent implantationSingle-arm study, no placebo or control group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic coronary multivessel disease
- possible percutaneous complete coronary revascularization
- age >18 year
- significant coronary lesion at least in 2 vessels
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracoronary stent implantationAlso: Taxus Express, Taxus LiberteTaxus stent implantation in patients with multivessel coronary artery disease | Device | 1 |
Primary outcome
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)
Time frame: 2 year
4 secondary outcomes
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
Time frame: 2 year
Incidence of 30-days, 6-mo and 1-year MACCE
Time frame: 1 year
Acute, subacute and late thrombosis rates
Time frame: 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
Time frame: 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2008.
- Derived from this study: PubMed 19695539Gyongyosi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut-Dietmar Glogar, MD FESC principal investigator
Dept. Cardiology, Medical University of Vienna, Vienna, Austria
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intracoronary stent implantation in people with Coronary Artery Disease, run by Medical University of Vienna at 7 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.