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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01199419
Other study ID # Version 1
Secondary ID
Status Completed
Phase N/A
First received September 9, 2010
Last updated July 16, 2014
Start date January 2004
Est. completion date July 2014

Study information

Verified date July 2014
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial Summary

The objective of the present study is to analyze the cost-effectiveness of percutaneous coronary intervention (PCI) using TAXUS stents compared to the costs of coronary artery bypass surgery (CABG) in patients with multivessel coronary artery disease (CAD) in the first 5 years and then 10 years after intervention. Multivessel PCI or CABG was performed in 114 or 93 patients, respectively. Clinical outcomes, in terms of incidence of acute myocardial infarction (AMI), all-cause death, target vessel revascularization (TVR) and stroke, resource use and costs are analyzed prospectively over a 5 and 10-year follow-up (FUP) period. Overall costs consist of the baseline costs of the index procedure (PCI or CABG), clinical and angiographic procedure-related treatments during the entire FUP. The primary endpoint is cost-effectiveness and clinical effectiveness, defined as the reduction of the composite of major adverse cardiac and cerebrovascular events (MACCE).


Recruitment information / eligibility

Status Completed
Enrollment 207
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- two or three-vessel disease requiring percutaneous or surgical multivessel intervention with the aim of complete revascularization

- age > 18 years

- clinical symptoms (stable or unstable angina) or signs of myocardial ischemia

- = 50% diameter stenosis of each lesion

Exclusion Criteria:

- acute myocardial infarction (< 48 h);

- contraindications to clopidogrel, aspirin, heparin and taxol;

- pregnancy or lack of protection against pregnancy or breast-feeding during the study;

- hemorrhagic diathesis and platelet count <100.000/ml3

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
comparison of PCI vs. CABG in multivessel disease
invasive treatment of coronary artery disease

Locations

Country Name City State
Austria Medical University of Vienna, Dept. of Cardiology 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 Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. in-hospital phase (up to 3 weeks) Yes
Primary Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. 6 months Yes
Primary Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. 12 months Yes
Primary Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. 5 years Yes
Primary Cost-effectiveness of percutaneous coronary intervention with Taxus stents compared to CABG in patients with multivessel coronary artery disease. 10 years Yes
Secondary Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke 6 months Yes
Secondary Rate of target vessel revascularization 6 months Yes
Secondary Occurrence of non-fatal acute myocardial infarction 6 months Yes
Secondary Occurrence of cardiac death 6 months Yes
Secondary Calculation of the total costs in-hospital phase (up to 3 weeks) Yes
Secondary Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke 12 months Yes
Secondary Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke 5 years Yes
Secondary Occurrence of MACCE, defined as cardiac death, nonfatal myocardial infarction, target vessel revascularization and stroke 10 years Yes
Secondary Rate of target vessel revascularization 12 months Yes
Secondary Rate of target vessel revascularization 5 years Yes
Secondary Rate of target vessel revascularization 10 years Yes
Secondary Occurrence of non-fatal acute myocardial infarction 12 months Yes
Secondary Occurrence of non-fatal acute myocardial infarction 5 years Yes
Secondary Occurrence of non-fatal acute myocardial infarction 10 years Yes
Secondary Occurrence of cardiac death 12 months Yes
Secondary Occurrence of cardiac death 5 years Yes
Secondary Occurrence of cardiac death 10 years Yes
Secondary Calculation of the total costs 6 months Yes
Secondary Calculation of the total costs 12 months Yes
Secondary Calculation of the total costs 5 years Yes
Secondary Calculation of the total costs 10 years Yes
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