Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-25 @ 2:47 AM
NCT ID:
NCT03316833
Eligibility Criteria:
Inclusion Criteria:
* Subject \> 18 years old
* ULMCAD with angiographic diameter stenosis \>50% (if 50-70% evidence of FFR \<0.80 or IVUS minimal lumen area \<6.0 mm2 is recommended.
* Silent ischemia, stable angina, unstable angina or non-ST elevation myocardial infarction
* Ability to provide written informed consent and comply with follow-up for at least 2 years.
Exclusion Criteria:
1. Clinical exclusion criteria:
* Prior PCI on the left main trunk or prior CABG.
* Concomitant indication to cardiac surgery (severe heart valve disease etc.)
* Cardiogenic Shock (Killip\>2)
* Severe renal insufficiency (GFR \<30 ml/min)
* Known impaired left ventricular function (left ventricular ejection fraction \<30%)
* Inability to tolerate or comply with dual antiplatelet therapy for at least 1 year
* Pregnancy or intention to become pregnant
* Life expectancy less than 1 year
* Other investigational drug or device studies that have not reached their primary endpoint
2. Angiographic exclusion criteria:
* Left main diameter stenosis \<50%
* SYNTAX score \>33
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03316833
Study Brief:
Protocol Section:
NCT03316833