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

Recruiting

Conditions: Non-STEMI and multivessel disease
10011082

Registration Number: NL-OMON50726

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 414

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

• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints are defined as the incidence of MACE (Composite<br /><br>endpoint of all cause death, non-fatal Myocardial Infarction, any<br /><br>revascularisation and stroke) at 12 months.</p><br>

Secondary Outcome Measures

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