PROtection of coronary Microcirculation by Iloprost:Safety and Efficacy in Percutaneous Coronary Intervention - PROMISE PCI
- Conditions
- Coronary heart disease with stable angina or non-ST elevation myocardial infarction (NSTEMI)MedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome
- Registration Number
- EUCTR2008-001319-39-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1.Age > 18 y
2.Stable angina or inducible ischemia
3.Acute myocardial infarction without ST elevation (NSTEMI)
4.Planned angioplasty on one, two or three coronary lesions
5.Informed Consent
Subgroup with coronary flow study
Acute myocardial infarction without ST elevation (NSTEMI)
Planned angioplasty on only one stenosis or on double lesion on single vessel
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.Atrial fibrillation (cases with coronary flow study)
2.ST elevation acute myocardial infarction (STEMI)
3.Contraindications to anti-platelet therapy or IIb/IIIa inhibitors
4.Hypertension (> 180/100 mmHg)
5.Planned angioplasty on more than three coronary stenoses
6.Two or more of the following procedural characteristics: stenoses in coronary bifurcations, multiple stenoses, stenoses in saphenous aorto-coronary grafts
7.Pregnancy or fertile age
Subgroup with coronary flow study
Atrial fibrillation
Proximal tortuosity of the vessel
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