Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.
Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.
To compare MiStent to either the Xience or Promus stents.with the primary objective being to
 assess the safety and efficacy of the MiStent in a patient population requiring
 revascularization of de novo obstructive lesions of coronary arteries in patients with stable
 and unstable coronary artery disease (CAD) including non ST-Elevation Myocardial Infarction
 (NSTEMI)
The CRYSTAL study is a prospective, multi-center, randomized (1:1), single-blinded and
 controlled, investigational device exemption trial to test the non-inferiority of MiStent to
 commercially available "everolimus" drug eluting stents (Xience and Promus stents).

 Patients with coronary artery disease (CAD) that qualify for percutaneous coronary
 intervention (PCI) with stenting will be screened per the protocol inclusion and exclusion
 criteria.
Inclusion Criteria:

 1. Subject must be ≥ 18 years of age

 2. Subject (or legal guardian) understands the trial requirements and the treatment
 procedures and provides written informed consent before any trial-specific tests or
 procedures are performed

 3. Subject is eligible for percutaneous coronary intervention (PCI)

 4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or
 silent ischemia

 5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)

 6. Subject is willing to comply with all protocol-required follow-up evaluation

 Angiographic Inclusion Criteria (visual estimate):

 7. Target lesion(s) must be located in a native coronary artery with a visually estimated
 reference vessel diameter (RVD) ≥2.50 mm and ≤3.50 mm

 8. Target lesion(s) must be able to be treated with a single stent and the target lesion
 length must be ≤27 mm (by visual estimate).

 NOTE: Only lesion lengths that have both the control and comparable investigational
 stent lengths available at the same time are eligible for enrollment.

 9. Target lesion(s) must have visually estimated stenosis ≥50% and <100% with
 thrombolysis in Myocardial Infarction (TIMI) flow >1 and one of the following:

 1. Stenosis ≥70% or;

 2. Abnormal fractional flow reserve (FFR) defined as <0.80 or;

 3. Abnormal stress or imaging stress test or;

 4. Elevated biomarkers prior to the procedure

 10. Coronary anatomy is likely to allow delivery of a study device to the target
 lesions(s)

 11. The first lesion treated must be successfully predilated/pretreated

 Exclusion Criteria:

 1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with
 acute ST elevation MI (STEMI)

 2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or
 mechanical circulatory support, intractable ventricular arrhythmias, or ongoing
 intractable angina

 3. Subject has received an organ transplant or is on a waiting list for an organ
 transplant

 4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or
 after the index procedure

 5. Planned PCI (including staged procedures) or CABG after the index procedure

 6. Subject previously treated at any time with intravascular brachytherapy in the target
 vessel(s)

 7. Subject has a known allergy to contrast (that cannot be adequately premedicated)
 and/or the trial stent system or protocol-required concomitant medications (e.g.,
 Cobalt-chromium alloy, stainless steel, everolimus or structurally related compounds,
 polymer or individual components, all P2Y12 inhibitors, or aspirin)

 8. Subject has one of the following (as assessed prior to the index procedure):

 1. Other serious medical illness (e.g., cancer, congestive heart failure) with
 estimated life expectancy of less than 24 months

 2. Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)

 3. Planned procedure that may cause non-compliance with the protocol or confound
 data interpretation

 9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin,
 coumadin, or other anticoagulation therapy) for indications other than acute coronary
 syndrome

 10. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3

 11. Subject has a white blood cell (WBC) count < 3,000 cells/mm3

 12. Subject has documented or suspected liver disease, including laboratory evidence of
 hepatitis

 13. Subject is on dialysis or has baseline glomerular filtration rate (GFR) of <30 ml/min

 14. Subject has a history of bleeding diathesis, active peptic ulcer or gastrointestinal
 (GI) bleed, or coagulopathy or will refuse blood transfusions

 15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic
 attack (TIA) within the past 6 months

 16. Subject has severe symptomatic heart failure (i.e., Left Ventricular Ejection Fraction
 (LVEF) <30%))

 17. Subject is participating in another investigational drug or device clinical trial that
 has not reached its primary endpoint

 18. Subject intends to participate in another investigational drug or device clinical
 trial within 12 months after the index procedure

 19. Subject with known intention to procreate within 12 months after the index 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 index
 procedure)

 20. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed
 within 7 days prior to the index procedure in women of child-bearing potential)

 Angiographic Exclusion Criteria (visual estimate):

 21. Planned treatment of a single lesion with more than 1 stent

 22. Planned treatment of more than 3 lesions

 23. Planned treatment of lesions in more than 2 major epicardial vessels

 24. Planned treatment of more than 2 lesions in a single major epicardial vessel

 25. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm
 (by visual estimate)

 26. Target lesion(s) is located in the left main or unprotected left

 27. Target lesion(s) is located within 3 mm of the origin of the left anterior descending
 (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate

 28. Target lesion(s) is located within a saphenous vein graft or an arterial graft

 29. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft

 30. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide
 wire crossing

 31. Target lesion(s) treated during the index procedure that involves a complex
 bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)

 32. Target lesion(s) is restenotic from a previous stent implantation or study stent would
 overlap with a previous stent

 33. Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent,
 cutting balloon atherectomy) within 24 hours prior to the index procedure

 34. Significant thrombus, present in the target vessel (by visual estimate)