NIRTRAKS Post-Market Study (NIRTRAKS)

Inclusion Criteria

General

• Subject is ≥18 years old.
• Subject is eligible for percutaneous coronary intervention (PCI).
• Subject is eligible for dual anti-platelet therapy (DAPT) with aspirin plus either clopidogrel, prasugrel or ticagrelor for a minimum of 1 month.
• Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
• Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
• Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• 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]).
• Female subjects of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment in the study.

Angiographic Inclusion Criteria

• Subject is indicated for elective stenting of a single stenotic lesion in a native coronary artery.
• Reference vessel ≥2.5 mm and ≤4.0 mm in diameter by visual estimate.
• Target lesion ≤30 mm in length by visual estimate (the intention should be to cover the whole lesion with 1 stent of adequate length).
• Target lesion stenosis ≥50% and 2.5 mg/dL within 7 days prior to the index procedure.
• Subject was previously enrolled in the PIONIR Study or the NIRTRAKS Post-Market Study.

Angiographic Exclusion Criteria

• 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).
• 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).
• Target lesion exhibiting an intraluminal thrombus (occupying >50% of the true lumen diameter) at any time prior to the start of the intervention.
• Lesion location that is aorto-ostial or within 5 mm of the origin of the LAD or LCX.
• Target lesion with side branches >2.0 mm in diameter.
• Target lesion involving a bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch).
• Target lesion with severe calcification.
• Target vessel exhibiting excessive tortuosity that may impede stent delivery and deployment at target lesion.
• 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.