Trial to Demonstrate the Safety and Effectiveness of the MiStent II for the Revascularization of Coronary Arteries.

Korábbi kezelés

• Subject has received an organ transplant or is on a waiting list for an organ transplant
• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• Subject previously treated at any time with intravascular brachytherapy in the target vessel(s)
• 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)
• Subject has one of the following (as assessed prior to the index procedure):
  • Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 24 months
  • Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
  • Planned procedure that may cause non-compliance with the protocol or confound data interpretation
• Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin, or other anticoagulation therapy) for indications other than acute coronary syndrome
• Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
• 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):
• Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
• Target lesion(s) treated during the index procedure that involves a complex bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)
• Target lesion(s) is restenotic from a previous stent implantation or study stent would overlap with a previous stent
• 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

Más betegség

• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• Subject has a history of bleeding diathesis, active peptic ulcer or gastrointestinal (GI) bleed, or coagulopathy or will refuse blood transfusions
• Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months

Laborértékek

• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
• Subject has a white blood cell (WBC) count \< 3,000 cells/mm3
• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
• Subject is on dialysis or has baseline glomerular filtration rate (GFR) of \<30 ml/min
• Subject has severe symptomatic heart failure (i.e., Left Ventricular Ejection Fraction (LVEF) \<30%))

Egyéb

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
• Planned PCI (including staged procedures) or CABG after the index procedure
• 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)
• Planned treatment of a single lesion with more than 1 stent
• Planned treatment of more than 3 lesions
• Planned treatment of lesions in more than 2 major epicardial vessels
• Planned treatment of more than 2 lesions in a single major epicardial vessel
• Subject has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate)
• Target lesion(s) is located in the left main or unprotected left
• 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
• Target lesion(s) is located within a saphenous vein graft or an arterial graft
• Target lesion(s) will be accessed via a saphenous vein graft or arterial graft
• Significant thrombus, present in the target vessel (by visual estimate)

• Subject must be ≥ 18 years of age
• 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
• Subject is eligible for percutaneous coronary intervention (PCI)
• Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia
• Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
• Subject is willing to comply with all protocol-required follow-up evaluation
  • Angiographic Inclusion Criteria (visual estimate):
• 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
• 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.
• Target lesion(s) must have visually estimated stenosis ≥50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1 and one of the following:
  • Stenosis ≥70% or;
  • Abnormal fractional flow reserve (FFR) defined as \<0.80 or;
  • Abnormal stress or imaging stress test or;
  • Elevated biomarkers prior to the procedure
• Coronary anatomy is likely to allow delivery of a study device to the target lesions(s)
• The first lesion treated must be successfully predilated/pretreated