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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02817802
Eligibility Criteria:
Inclusion cirteria
1. Subject is ≥18 years of Age
2. Subject must be willing to sign a Patient Informed Consent (PIC) or Patient Data Release Form (PDRF) where applicable
3. Symptomatic coronary artery disease
4. Subject with a maximum of two single de novo lesions in two different major epicardial vessels
5. Target lesion length ≤21 mm by QCA or by visual estimation
6. Target lesion stenosis by visual estimation: \>50% - \<100% and TIMI flow ≥1
7. Subject is eligible for Dual Anti Platelet Therapy (DAPT)
8. Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used
Exclusion criteria
1. Pregnant and/or breast feeding females or females who intend to become pregnant during the time of the registry
2. Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant/antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs; or the scaffold materials including Magnesium, Yttrium, Neodymium, Zirconium,Gadolinium, Dysprosium, Tantalum that cannot beadequately pre-medicated
3. Subjects on dialysis
4. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST Elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
5. Documented left ventricular ejection fraction (LVEF) \<30%
6. Restenotic target lesion
7. Thrombus in target vessel
8. Target lesion is located in or supplied by a diseased (defined as vessel irregularity per angiogram and \>20% stenosed lesion by visual estimation) arterial or venous bypass graft
9. Left main coronary artery disease
10. Ostial target lesion (within 5.0 mm of vessel origin)
11. Target lesion involves a side branch ≥2.0 mm in Diameter
12. Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion
13. Unsuccessful pre-dilatation, defined as residual Stenosis rate more than 20% measured by QCA and / or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
14. Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
15. Currently participating in another study and Primary endpoint is not reached yet.
16. Planned interventional treatment of any target or nontarget vessel
Participating Countries
Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Malaysia, New Zealand, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Kingdom
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02817802
Study Brief:
Protocol Section:
NCT02817802