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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT02698618
Eligibility Criteria:
Inclusion Criteria:
* Subject with Diabetes Mellitus (DM) Type II
* Subject must be older than 18 years
* Written informed consent available
* Subject with stable ischemic heart disease referred for coronary angiography
* Subject is eligible for PCI, and PCI target(s) have FFR≤0.80
Exclusion Criteria:
* Prior myocardial infarction in the territory of the target vessel
* Akinesia or dyskinesia in subtended myocardial segments
* Severe impairment of left ventricular function (LVEF) \<35%
* PCI target is a chronic total occlusion
* Target lesion has been treated previously (restenotic lesions)
* Target vessel is a saphenous vein graft or a surgical graft has been anastomosed to target vessel
* Thrombolisis in Myocardial Infarction (TIMI) flow ≤ 1 prior to guide wire crossing
* Subject is not eligible for treatment with DES
* Bleeding disorders or chronic anticoagulant treatment
* Left main stenosis \> 50%
* Coronary surgery deemed more beneficial for the patient than PCI
* Intolerance or contraindications to anti-platelet drugs
* Contraindications for adenosine administration
* Platelet count \<75000 or \>700000/mm3
* Immunosuppressive therapy
* Pregnant or breast feeding patient
* History of intracranial haemorrhage
* Severe hepatic impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02698618
Study Brief:
Protocol Section:
NCT02698618