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:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT02683356
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years.
2. Patient provides signed written informed consent before any study-specific procedure.
3. De novo native coronary artery disease with lesions that have a distal and proximal reference vessel diameter in the range between 2.25mm and 3.8mm.
4. Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated at baseline with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
5. Full revascularization of all lesions should be achievable (staged PCI not recommended)
6. Elective or ad hoc PCI, stable angina and acute coronary syndrome (NSTE-ACS and STEMI).
7. Angiographically significant (\>50% visual estimation) stenosis present in at least one native coronary artery and evidence of ischemia.
Exclusion Criteria:
1. Subjects with left main lesion.
2. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
3. Subjects with restenosis or stent thrombosis in the target vessel.
4. Severely calcified lesions requiring rotablation.
5. Bifurcation with sidebranch \>2.5mm or any sidebranch that possibly requires treatment with angulation \>70°
6. Severe angulation (\>90°) or excessive tortuosity (\>two 45° angles)
7. Known renal insufficiency (serum creatinine clearance \<45ml/min or receiving dialysis).
8. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
9. Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
10. Life expectancy less than 1 year.
11. Indication for oral anticoagulation
12. Known allergy against protocol-required medications including ASA, prasugrel, ticagrelor, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated)
13. History of bleeding diathesis or known coagulopathy.
14. Planned surgery within the next 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02683356
Study Brief:
Protocol Section:
NCT02683356