Skip to main content
Clinical Trials/EUCTR2013-002210-12-ES
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

Population Health Research Institute0 sites3,900 target enrollmentDecember 16, 2014

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.

Registry
who.int
Start Date
December 16, 2014
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

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

Similar Trials