coronary angioplasty MedDRA version: 9.1 Level: LLT Classification code 10050329 Term: Coronary angioplasty
Conditions
Interventions
Trade Name: ENDOPROST 50*INFUS 1F 0,050MG/
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Iloprost
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Complete block of left branch Previous myocardial infarct Arterial Hypertension (> 180/100 mmHg) Pregnancy or fruitful age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed