Comparison of complete vs single vessel revascularization in patients with coronary artery disease.
- Conditions
- Effectiveness study of complete versus culprit-only revascularization strategies to treat multi vessel disease after primary PCI for STEMITherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-002210-12-ES
- Lead Sponsor
- Population Health Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 3900
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method