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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT02455804
Eligibility Criteria:
Inclusion Criteria:
General
1. Subject is ≥18 years old.
2. Subject is eligible for percutaneous coronary intervention (PCI).
3. Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel or ticagrelor for a minimum of 1 month.
4. Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
5. Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
6. Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery.
7. Subject has stable angina pectoris (Canadian Cardiovascular Society Classification \[CCSC\] 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g. exercise tolerance test \[ETT\], single-photon emission computerized tomography \[SPECT\], stress echocardiography or cardiac computerized tomography \[CT\]).
8. Female subjects of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment in the study.
Angiographic Inclusion Criteria
1. Subject is indicated for elective stenting of a single stenotic lesion in a native coronary artery.
2. Reference vessel ≥2.5 mm and ≤4.0 mm in diameter by visual estimate.
3. Target lesion ≤30 mm in length by visual estimate (the intention should be to cover the whole lesion with 1 stent of adequate length).
4. Target lesion stenosis ≥50% and \<100% by visual estimate.
Exclusion Criteria:
General Exclusion Criteria
1. Subject is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
2. Subject was enrolled in another stent trial within 2 years prior to the index procedure.
3. Any planned elective surgery or percutaneous intervention within 9 months post- procedure.
4. A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
5. The subject requires staged procedure of either the target vessel or any non-target vessel within 9 months post-procedure.
6. The target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
7. Previous drug-eluting stent (DES) deployment anywhere in the target vessel.
8. Any previous DES deployment within the past 12 months.
9. Any previous stent placement within 15 mm proximal or distal to the target lesion.
10. Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
11. Concurrent medical condition with a life expectancy of \<3 years.
12. Documented left ventricular ejection fraction (LVEF) \<25% at the most recent evaluation.
13. Evidence of an acute MI within 72 hours of the intended index procedure.
14. History of cerebrovascular accident or transient ischemic attack within 6 months prior to the index procedure.
15. Leukopenia (leukocytes \<3.5 x 109/liter).
16. Neutropenia (absolute neutrophil count \<1,000/mm3) ≤ within 7 days prior to enrollment.
17. Thrombocytopenia (platelets \<100,000/mm3) pre-procedure (within 7 days prior to enrollment).
18. Active peptic ulcer or active gastrointestinal (GI) bleeding.
19. Subjects who are ineligible for ≥1 month of DAPT because of bleeding diathesis or any other reason.
20. Known hypersensitivity or contraindication to aspirin, thienopyridine, both heparin and bivalirudin, cobalt, nickel, L-605 cobalt chromium alloy or sensitivity to contrast media which cannot be adequately pre-medicated.
21. Serum creatinine level \>2.5 mg/dL within 7 days prior to the index procedure.
22. Subject was previously enrolled in the PIONIR Study or the NIRTRAKS Post-Market Study.
Angiographic Exclusion Criteria
1. Unprotected left main coronary artery disease (obstruction \>50% in the left main coronary artery that is not protected by ≥1 non-obstructed bypass graft to the left anterior descending \[LAD\] or left circumflex \[LCX\] artery or a branch thereof).
2. Target vessel exhibiting multiple lesions with \>60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line quantitative coronary angiography (QCA).
3. Target lesion exhibiting an intraluminal thrombus (occupying \>50% of the true lumen diameter) at any time prior to the start of the intervention.
4. Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX.
5. Target lesion with side branches \>2.0 mm in diameter.
6. Target lesion involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch).
7. Target lesion with severe calcification.
8. Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion.
9. Target lesion that is located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02455804
Study Brief:
Protocol Section:
NCT02455804