Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY)

Exclusion Criteria

• •1. Subject unwilling or unlikely to comply with the one-year duration of the study as in the opinion of the investigator.
• •2. Subject is pregnant, breast-feeding, or is a woman of childbearing potential who is not using appropriate contraceptives.
• •3. Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
• •4. Stroke within 90 days of the index procedure.
• •5. Documented left ventricular ejection fraction (LVEF) \<35% by echocardiography.
• •6. In-stent restenosis occurring in less than 90 days prior to the index procedure.
• •Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.
• •8\. History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.
• •9\. Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, drug balloon coatings and their excipients, including, but not limited to, paclitaxel, sirolimus, or zotarolimus, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
• •10\. The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
• •11\. Known allergy to nitinol or nickel.
• •12\. Any expected elective surgical procedure that would necessitate interruption of DAPT through the 12-month visit.
• •13\. Planned use of atherectomy (rotational, orbital, or laser) device, cutting or scoring balloon.
• •14\. Severe hepatic dysfunction (3 times normal reference values).
• •15\. Planned treatment of additional lesions in target vessel or \> two (2) non-target lesions within non-target vessels during index procedure.
• •16\. Target lesion has undergone \> two (2) prior stent implant procedures (including the initial index procedure, i.e., \> two (2) layers of stent are present at any segment of target lesion).
• •1. Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
• •2. Fractured or otherwise compromised stents in the target vessel or inflow vessel.
• •3. Target lesion and vessel tortuosity must accommodate the Drug-eluting Coronary Spur.
• •4. Severe Calcification of the target vessel.
• •5. Prior history of repeat drug-eluting stent implantation for DES restenosis.
• •6. Angiographic evidence of thrombus within target artery.
• •7. Type D dissections or greater incurred during predilitation or crossing (see Appendix II for definitions).
• •8. Tortuosity of proximal segment or location of In-stent Restenosis (ISR) or extremely angulated segments which prevents tracking of the Coronary Spur Stent to the target lesion.
• •9. Total occlusions \> 3 months old and/or bridging collaterals.