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 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03399994
Eligibility Criteria:
Inclusion Criteria:
1. Age\>18
2. Diabetes mellitus
3. Documented CAD: stable or unstable angina, Non-ST segment MI, silent ischemia or positive functional study
4. PCI considered appropriate and feasible
5. Culprit de novo lesion in a native coronary artery with significant stenosis (\>50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length);
6. Patient provides written informed consent
7. Patient agrees to all required follow-up procedures and visits.
8. Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm.
Exclusion Criteria:
1. The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus, everolimus, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled);
2. Any contraindication to the implant of the Abluminus DES+
3. Subject is pregnant, nursing, or is a woman of child-bearing potential who is not surgically sterile, 2 years postmenopausal, or does not consistently use effective methods of contraception;;
4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
5. Previous coronary intervention on target vessel in the 3-months prior to enrollment;
6. Non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
7. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
8. Previously documented left ventricular ejection fraction (LVEF) \<30%;
9. Evident cardiogenic shock before randomization;
10. Patients with left main stem stenosis (\>50% by visual estimate);
11. In-stent restenosis;
12. ST-segment elevation MI;
13. Chronic total occlusion.
14. Culprit lesion to a Saphenous Vein graft
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03399994
Study Brief:
Protocol Section:
NCT03399994