Status:
UNKNOWN
FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Whether to revascularize patients with angiographically-intermediate coronary lesions (AICL) is a major clinical issue. Intravascular techniques (assessing either the anatomy or the functional effect ...
Eligibility Criteria
Inclusion
- single vessel disease with an intermediate coronary artery stenosis
- multivessel disease with multiple intermediate coronary artery stenosis only
- multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis
Exclusion
- age \<18 years or impossibility to give informed consent,
- female sex with child-bearing potential,
- life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc),
- poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
- recent (\< 7 days) ST-segment elevation myocardial infarction
- recent (\< 48 hours) Non ST-segment elevation myocardial infarction
- prior ST-segment elevation myocardial infarction in the territory supplied by the vessel with the intermediate stenosis under investigation
- severe myocardial hypertrophy (interventricular septum thickness \> 15 mm, ECG Sokolow's criteria fulfilled)
- severe valvular heart disease
- significant platelet count alteration (\<100,000 cells/mm3 or \> 700,000 cells/mm3)
- gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks
- history of clotting pathology
- known hypersensitivity to aspirin, heparin, contrast dye
- advance renal failure with glomerular filtration rate \< 30 ml/min
- lesions in coronary artery bypass grafts
- multivessel disease requiring coronary aortic bypass graft intervention
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01824030
Start Date
April 1 2013
End Date
April 1 2016
Last Update
April 9 2013
Active Locations (1)
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1
Policlinico A. Gemelli. Università Cattolica del Sacro Cuore
Rome, Italy, 00168