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

Pre-Procedure Inclusion Criteria:

1. Subject willing and able to provide informed consent and able to comply with thestudy protocol and follow up. Subjects who are unable to sign due to a physicallimitation may have a legal guardian or legally authorized representative (LAR) signon their behalf.

2. Life expectancy greater than 2 years in the investigator's opinion.

3. Subject is greater than 18 years of age.

4. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 daysbefore the procedure.

5. Endovascular treatment is able to be conducted under non-emergent conditions.

6. Documented stable or unstable angina including non-ST-elevation MI, functionaltesting demonstrating ischemia, and/or clinical symptoms that in the opinion of theinvestigator are not amenable to conservative medical therapy and requireendovascular intervention.

7. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plusP2Y12 inhibitor.

Angiographic Inclusion Criteria:

1. Target vessel is of appropriate size and diameter to be treated with the CoronarySpur Stent.

2. Target lesion is within a previously placed Bare Metal Stent (BMS) or Drug-elutingStent (DES) and does not extend further than 5mm beyond either the proximal ordistal edge of the stent.

3. In-stent restenosis of >50% diameter by angiography.

4. Up to two (2) non-target lesions in non-target vessels may be treated, butsuccessful percutaneous coronary intervention (PCI) of the non-target lesions mustbe completed before treatment of the target lesion. Successful treatment of anon-target lesion is defined as a residual stenosis of ≤ 30% in 2 near-orthogonalprojections with Thrombolysis in Myocardial Infarction (TIMI) 3 flow, as visuallyassessed by the physician, without the occurrence of prolonged chest pain or ECGchanges consistent with MI.

5. Successful pre-dilatation of the target lesion, defined as non-compromised flow orpresence of thrombus.

Pre-procedure Exclusion Criteria:

1. Subject unwilling or unlikely to comply with the one-year duration of the study asin the opinion of the investigator.

2. Subject is pregnant, breast-feeding, or is a woman of childbearing potential who isnot using appropriate contraceptives.

3. Subject has an active systemic infection that is not controlled at the time of theprocedure, 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 orother inability to comply with recommended duration of DAPT.

9. Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulanttherapies which could not be substituted, drug balloon coatings and theirexcipients, including, but not limited to, paclitaxel, sirolimus, or zotarolimus, oran allergy to contrast media that cannot be adequately pre-treated prior to theindex procedure.

10. The subject is currently enrolled in another investigational device or drug trialthat interferes with the study endpoints.

11. Known allergy to nitinol or nickel.

12. Any expected elective surgical procedure that would necessitate interruption of DAPTthrough the 12-month visit.

13. Planned use of atherectomy (rotational, orbital, or laser) device, cutting orscoring balloon.

14. Severe hepatic dysfunction (3 times normal reference values).

15. Planned treatment of additional lesions in target vessel or > two (2) non-targetlesions within non-target vessels during index procedure.

16. Target lesion has undergone > two (2) prior stent implant procedures (including theinitial index procedure, i.e., > two (2) layers of stent are present at any segmentof target lesion).

Angiographic Exclusion Criteria

1. Target lesion is located within an aneurysm or associated with an aneurysm in thevessel 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 (seeAppendix II for definitions).

8. Tortuosity of proximal segment or location of In-stent Restenosis (ISR) or extremelyangulated segments which prevents tracking of the Coronary Spur Stent to the targetlesion.

9. Total occlusions > 3 months old and/or bridging collaterals.