| Eligibility |
General Inclusion:
1. Stable patients (non-ACS) with an indication for possible PCI for stable angina,
and/or silent ischemia (in absence of symptoms a visually estimated target lesion
diameter stenosis of =70%, a positive non-invasive stress test, or Fractional Flow
Reserve (FFR) =0.80 must be present).
2. Patient is willing and able to provide informed written consent and comply with
follow-up visits and testing schedule
Angiographic Inclusion Criteria:
1. Target lesion(s) must be located in a native coronary artery or bypass graft conduit
with visually estimated diameter of =2.5mm to =4.25mm
2. Complex lesions are allowed including calcified lesions (lesion preparation with
scoring/cutting and rotational atherectomy are allowed), presence of thrombus that is
non-occlusive and does not require thrombectomy, chronic total occlusion (CTO),
bifurcation lesions (except planned dual stent implantation), ostial RCA lesions,
tortuous lesions, bare metal stent restenotic lesions, protected left main lesions,
and saphenous vein graft lesions.
3. Overlapping stents are allowed
General Exclusion Criteria:
1. PCI with previous BioNIR stent implantation.
2. ACS within 1 month of enrollment.
3. Patients receive strong CYP3A inhibitors or inducers such as Ketoconazole or Rifampin.
4. PCI within the 24 hours preceding the baseline procedure.
5. Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.
6. History of stent thrombosis.
7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90
mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support,
including intra aortic balloon pumping (IABP).
8. Subject is intubated.
9. Known left ventricular ejection fraction (LVEF) <30%.
10. Relative or absolute contraindication to duale antiplatelet therapy (DAPT) for 12
months (including planned surgeries that cannot be delayed)
11. Subject has an indication for chronic oral anticoagulant treatment (with either
vitamin K antagonists or novel anticoagulants (NOACs)
12. Calculated creatinine clearance <30 mL/min using Cockcroft-Gault equation.
13. Hemoglobin <10 g/dL.
14. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
15. White blood cell (WBC) count <3,000 cells/mm3.
16. Clinically significant liver disease.
17. Active peptic ulcer or active bleeding from any site.
18. Bleeding from any site within the prior 8 weeks requiring active medical or surgical
attention.
19. If femoral access is planned, significant peripheral arterial disease which precludes
safe insertion of a 6French (6F) sheath.
20. History of bleeding diathesis/coagulopathy/will refuse blood transfusions.
21. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any
permanent neurologic defect attributed to cerebrovascular accident (CVA).
22. Known allergy to the study stent components, e.g. cobalt, nickel, chromium,
molybdenum, Carbosil®, PBMA, Biolinx polymer, or limus drugs (ridaforolimus,
zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue
or derivative or similar compounds).
23. Known allergy to protocol-required concomitant medications such as aspirin, or DAPT
(clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated
contrast that cannot be adequately pre-medicated.
24. Any co-morbid condition that may cause non-compliance with the protocol (e.g.
dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g.
cancer, severe heart failure, severe lung disease).
25. Patient participating in or plans to participate in any other investigational drug or
device clinical trial that has not reached its primary endpoint.
26. Women who are pregnant or breastfeeding (women of child-bearing potential must have a
negative pregnancy test within 1week before treatment).
27. Women who intend to become pregnant within 12 months after the baseline procedure
(women of child-bearing potential who are sexually active must agree to use a reliable
method of contraception from the time of screening through 12 months after the
baseline procedure).
28. Patient has received / is on a waiting list for an organ transplant.
29. Patient is receiving or scheduled to receive chemotherapy within 30 days before or any
time after the baseline procedure.
30. Patient is receiving oral or intravenous immunosuppressive therapy or has known
life-limiting immunosuppressive disease (e.g., HIV). Corticosteroids are allowed
Angiographic exclusion criteria:
31. Target lesions in more than two (2) major coronary arteries (ie, two of left anterior
descending artery [LAD], LCX, RCA) including their respective branches (the Ramus
Intermedius is defined as a branch of the LCX).
32. More than two target lesions per target vessel are planned (two lesions separated by
less than 10 mm that can be covered by a single stent are considered as one lesion).
33. More than 100mm length planned study stenting in entire coronary tree.
34. Occlusive thrombus and/or thrombus requiring thrombectomy in a target vessel.
35. Unprotected left main lesions =30%, or planned unprotected left main intervention.
36. Ostial LAD or LCX target lesions (stenting of any diseased segment within 5 mm of the
unprotected left main coronary artery).
37. Target Bifurcation lesions with planned dual stent implantation.
38. Stenting of target lesions due to DES restenosis.
39. Another lesion in a target or non-target vessel (including all side branches) is
present that requires or has a high probability of requiring PCI within 12 months
after the baseline procedure
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