Fractional Flow Reserve guide Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevatio Myocardial Infarction in Patients with Multivessel Coronary Disease

Fractional Flow Reserve guide Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevatio Myocardial Infarction in Patients with Multivessel Coronary Disease - COMPARE-ACUTE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41311

Enrollment

295

Registered

2011-05-26

Start date

2011-07-03

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI/ multivessel atheromatic -thrombotic coronary obstructions

Interventions

FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: STEMI patients, between 18-85 years, who will be treated with primary PCI50 % in a non IRA on QCA or visual estimation and judged feasible for treatment with PCI by the operator

Exclusion criteria

Exclusion criteria: Left main stem disease, chronic total occlusion of non-IRA, Severe stenosis with TIMI-flow

Design outcomes

Primary

Measure	Time frame
Composite endpoint of all cause mortality, non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months	—

Secondary

Measure	Time frame
Primary endpoint at 24 and 36 months as well as outcomes of each component of the primary endpoint at 12 months. Primary endpoint rates in the subgroup of patients receiving staged or acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients with FFR positive lesion that received optimal medical treatment Primary endpoint rates in the subgroup of patients receiving acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients receiving staged PCI treatment for FFR positive lesions in the non-IRA Primary endpoint rates in the subgroup of patients receiving staged PCI treatment for FFR negative lesions in the non-IRA vs the subgroup of patients not receiving PCI treatment for FFR negative lesions in the non-IRA at 3 years. Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events)	—

Measure

Time frame

Primary endpoint at 24 and 36 months as well as outcomes of each component of the primary endpoint at 12 months. Primary endpoint rates in the subgroup of patients receiving staged or acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients with FFR positive lesion that received optimal medical treatment Primary endpoint rates in the subgroup of patients receiving acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients receiving staged PCI treatment for FFR positive lesions in the non-IRA Primary endpoint rates in the subgroup of patients receiving staged PCI treatment for FFR negative lesions in the non-IRA vs the subgroup of patients not receiving PCI treatment for FFR negative lesions in the non-IRA at 3 years. Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12 months (NACE i.e. Net Adverse Clinical Events)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)