BIOTRONIK Orsiro Pre-Marketing Registration

BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With de Novo Coronary Artery Lesions-VI

The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES, in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment of coronary artery disease.

Clinical or call follow up visits will take place at 1, 6, 12, 24, 36, 48 and 60 months post procedure. At 9 months (+ 30 days) all subjects will undergo a standard quantitative coronary angiography (QCA) follow up to assess the in-stent LLL as the main efficacious evaluation. Use the major adverse cardiac event (death, myocardial infarction and stent thrombosis) within one year post procedure as the main safety indicators to evaluate the investigational product's safety. The clinical and angiographic data sorting, calculation and statistical analysis will be conducted by an independent data management center and angiographic core laboratory.

Inclusion Criteria-Clinical

1. Subject who can understand the investigation's goal has provided written informed consent, and is willing to comply with the study's follow-up requirements.
2. Subject is ≥ 18 years and ≤ 75 years old, male or female without pregnant.
3. Subject is an acceptable candidate for PCI.
4. Subject has clinical evidence of asymptomatic ischemia, stable or unstable angina pectoris or old myocardial infarction.
5. Subject has no contraindication for dual anti-platelet therapy treatment.

Inclusion Criteria-Angiographic

1. Target lesion must be in the major coronary artery or a branch (target vessel).
2. Target lesion must have angiographic evidence of ≥ 70% and < 100% stenosis (by operator's visual estimate).
3. Subject has up to two target lesions (two target lesions in one target vessel, or for each target vessel, it has one target lesion).
4. Target lesion is suitable for drug-eluting stent PCI treatment.
5. Target lesion must be ≤ 36 mm in length by operator's visual estimate, and can be completely covered by one stent.
6. Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator's visual estimate.
7. Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥ 2.

Exclusion Criteria-Clinical

1. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
2. Subject has clinical symptoms and/or ECG changes consistent with acute ST elevation MI (STEMI) within 7 days prior to the index procedure, including hemodynamically unstable non-STEMI (NSTEMI) subjects.
3. Subject is hemodynamically unstable.
4. Subject is an unacceptable candidate for CABG.
5. Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA, sirolimus or everolimus.
6. Previous revascularization of any target or non-target vessel 9 months prior to the index procedure.
7. Planned surgery within 6 months of the index procedure.
8. Planned staged treatment during the index procedure or within 30 days after the index procedure.
9. History of a stroke or transient ischemic attack (TIA) within 12 months prior to the index procedure.
10. Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
11. Subject will refuse blood transfusions.
12. Subject has documented severe cardiac failure (over III level of NYHA) or left ventricular ejection fraction (LVEF) ≤ 40% as evaluated by echocardiogram, left ventricular angiography, radionuclide ventriculography or any non-invasive imaging method within 90 days prior to the index procedure.
13. Subject is dialysis-dependent.
14. Subject has impaired renal function (i.e., creatinine > 2.0 mg/dL or 175 μmol/L determined) within 7 days prior to the index procedure.
15. Subject has leukopenia (i.e. WBC < 3.5*10*9/L), thrombocytopenia (plt<100*10*9/L) or thrombocytosis (PLT>350*10*9/L).
16. Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
17. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are excluded), or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is excluded).
18. Subject has a life expectancy of < 3 years.
19. In the investigator's opinion, subject will not be able to comply with the follow-up requirements.
20. Subject is participating in another (medical device or drug) clinical study. Subjects may be concurrently enrolled in a post-market study, as long as the post-market study device, drug or protocol does not interfere with the investigational treatment or protocol of this study.

Exclusion Criteria-Angiographic

1. Target lesion is located within a saphenous vein graft or arterial graft.

2. Target lesion has any of the following characteristics:

   1. Lesion location is within the left main coronary artery, or within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX).
   2. Involves a side branch of > 2.5 mm in diameter. Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.

3. Target lesion is totally occluded (100% stenosis).

4. Target vessel has angiographic evidence of thrombus.

5. Target vessel/lesion is excessively tortuous/angulated or is severely calcified, preventing complete inflation of an angioplasty balloon.

6. Target vessel was treated with brachytherapy at any time prior to the index procedure.