FORWARD CAD IDE Study

Exclusion Criteria31

• Any comorbidity or condition which may prevent compliance with this protocol, including follow-up visits
• Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint
• Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
• Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
• Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
• Subject experienced an acute STEMI within 30 days prior to index procedure
• New York Heart Association (NYHA) class III or IV heart failure
• Subject has acute or chronic renal disease with eGFR \<30 ml/min/1.73m2 (using institutional formula)
• History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months
• Untreated pre-procedural hemoglobin \<10 g/dL or intention to refuse blood transfusions if one should become necessary
• Coagulopathy, including but not limited to platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
• Subject has a hypercoagulable disorder such as polycythemia vera, platelet count \>750,000 or other disorders
• Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
• Subjects with clinical evidence of cardiogenic shock
• Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
• Subjects with an estimated life expectancy of less than 1 year
• Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
• Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure
• Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
• Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL
• Unprotected left main diameter stenosis \>30%
• Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (dissection, perforation, abrupt closure, persistent slow-flow or persistent no reflow)
• Definite or possible thrombus by angiography in the target vessel
• Evidence of aneurysm in target vessel within 10 mm of the target lesion
• Second lesion with \>50% stenosis in the same target vessel as the target lesion including its side branches
• Chronic total occlusion of the target lesion, J-CTO ≥2
• Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
• Previous stent within 5 mm of the target lesion
• Failure to successfully cross the guidewire across the target lesion
• Planned use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), or retrograde dissection and reentry (RDR) crossing technique at any time during the procedure.