NIRTRAKS Post-Market Study (NIRTRAKS)
NIRTRAKS Post-Market Study (NIRTRAKS)
This is a prospective, post-marketing, non-randomized, multi-center, single-arm clinical
 study that will be conducted at up to 15 sites in the United States (US). All subjects will
 be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3
 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically
 warranted.
The main objective of this study is to collect and analyze additional information about the
 safety and effectiveness of the NIRxcell Stent System in the treatment of de novo stenotic
 lesions in native coronary arteries in the US population. The primary endpoint will be the
 rate of target vessel failure (TVF) at 3 years of treatment with the NIRxcell Stent System.
 This rate will be compared with a performance goal derived from a meta-analysis of coronary
 stenting with bare metal stents (BMS).
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.