EUCTR2013-002210-12-ES
Active, not recruiting
Phase 1
A randomized, comparative effectiveness study of complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction - COMPLETE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Population Health Research Institute
- Enrollment
- 3900
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3\-12 hours after initiation of fibrinolysis AND
- •2\. Multi\-vessel disease defined as at least 1 additional non\-infarct related coronary artery lesion that is at least 2\.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:
- •(i) at least 70% diameter stenosis (visual estimation) or
- •(ii) at least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ? 0\.80
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 1950
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 1950
Exclusion Criteria
- •1\. Planned revascularization of non\-culprit lesion
- •2\. Planned surgical revascularization
- •3\. Non\-cardiovascular co\-morbidity reducing life expectancy to \< 5 years
- •4\. Any factor precluding 5 year follow\-up
- •5\. Prior Coronary Artery Bypass Graft (CABG) Surgery
Outcomes
Primary Outcomes
Not specified
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