Ischemia (FFR) Driven Complete Revascularization versus Usual Care in Patients with Non-ST Elevation Myocardial Infarction and Multivessel Diseases.

Ischemia (FFR) Driven Complete Revascularization versus Usual Care in Patients with Non-ST Elevation Myocardial Infarction and Multivessel Diseases. - SLIM trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50726

Enrollment

414

Registered

2017-12-12

Start date

2018-06-07

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Non-STEMI and multivessel disease

Interventions

Patients will be enrolled and randomised in a 1:1 fashion between the ischemia driven (FFR) revascularisation strategy, versus usual care, after completion of a successful culprit lesion PCI. All pa

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Non-STEMI patients undergo successful PCI of the culprit lesion and have at least one stenosis of >=50% in a non-culprit lesion feasible for treatment with PCI.

Exclusion criteria

Exclusion criteria: • Left main stem disease (stenosis > 50%) • Chronic total occlusion of a non-culprit lesion • Indication for or previous Coronary artery bypass grafting • Known severe cardiac valve dysfunction that will require surgery or TAVI in the follow-up period. • Killip class III or IV during the completion of culprit lesion treatment. • Life expectancy of less than 1 year • Intolerance to Aspirin, or thienopyridine inhibitors or Heparin • Planned elective surgical procedure necessitating interruption of thienopyridines during the first 3 months post enrolment

Design outcomes

Primary

Measure	Time frame
Primary study endpoints are defined as the incidence of MACE (Composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke) at 12 months.	—

Secondary

Measure	Time frame
• Primary endpoint in subgroups at 12 and 24 months in the subgroup of patients. • Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any revascularisation, Stroke and major bleeding at 12, 24 and 36 months. • Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months. • All-cause mortality or Myocardial infarction at 12, 24 and 36 months.. • Any revascularisation at 12, 24 and 36 months. • Stent thrombosis at 12, 24 and 36 months. • Bleeding (major and minor) at 48 hr and 12 months • Primary endpoint at 36 months as well as outcomes of each component of the primary endpoint at 12 and 24 and 36 months. • Left ventricular ejection fraction at 12 (MIBI scan, MRI or Echocardiography)	—

Measure

Time frame

• Primary endpoint in subgroups at 12 and 24 months in the subgroup of patients. • Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any revascularisation, Stroke and major bleeding at 12, 24 and 36 months. • Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months. • All-cause mortality or Myocardial infarction at 12, 24 and 36 months.. • Any revascularisation at 12, 24 and 36 months. • Stent thrombosis at 12, 24 and 36 months. • Bleeding (major and minor) at 48 hr and 12 months • Primary endpoint at 36 months as well as outcomes of each component of the primary endpoint at 12 and 24 and 36 months. • Left ventricular ejection fraction at 12 (MIBI scan, MRI or Echocardiography)

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)