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PROtection of coronary Microcirculation by Iloprost:Safety and Efficacy evaluation in PCI - PROMISE

Conditions
coronary angioplasty
MedDRA version: 9.1Level: LLTClassification code 10050329Term: Coronary angioplasty
Registration Number
EUCTR2006-002726-32-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

Indication to elective coronary angioplasty
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

Complete block of left branch

Previous myocardial infarct

Arterial Hypertension (> 180/100 mmHg)

Pregnancy or fruitful age

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Study of Dose Finding conducts in an earlier phase to research the optimal physiological effect in terms of increase of the coronary flow and one following phase to research the tolerated maximum dose;Secondary Objective: Study of Dose Finding conducts in an earlier phase to research the optimal physiological effect in terms of increase of the coronary flow and one following phase to research the tolerated maximum dose;Primary end point(s): Measurement of the coronary flow by flow wire
Secondary Outcome Measures
NameTimeMethod
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