Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

Exclusion Criteria

• •1. Acute myocardial infarction within 30 days prior to baseline procedure.
• •2. Life expectancy \< 1 year.
• •3. Inability to use protocol-required concomitant medications (eg, aspirin, P2Y12 platelet receptor inhibitors, heparin, contrast agents, etc) due to allergy or other contraindications, and no alternative medications.
• •4. The target CTO has an iatrogenic dissection that occurred within the past 3 months.
• •5. Left ventricular ejection fraction less than 35%.
• •6. Severe aortic or mitral valve disease.
• •7. Planned left ventricular (LV) support device during CTO PCI.
• •8. Subjects with clear bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy.
• •9. Stroke, transient ischemic attack (TIA), or significant gastrointestinal (GI) bleeding within 6 months before the baseline procedure.
• •10. Planned additional coronary or valvular percutaneous or surgical intervention scheduled within 30 days after baseline procedure.
• •11. Subjects who require emergent or urgent PCI.
• •12. Female subjects who are pregnant or breast-feeding.
• •13. Subjects who are participating in another investigational drug or device clinical trial in which the primary endpoint is still not reached, or intend to participate in another investigational drug or device clinical trial within 12 months after baseline procedure.
• •14. Other medical illnesses that may cause the subject to be non-compliant with the protocol or confound data interpretation.
• •15. Serum creatinine \> 2.5 mg/dL (or 221 µmol/L), or on dialysis.
• •16. Hemodynamic instability or severely impaired activity tolerance (KILLIP Class III, IV, or NYHA Class III, IV).
• •17. Subjects with sustained tachyarrhythmia or cardiogenic shock.
• •1. The target CTO is in an unprotected left main.
• •2. No angiographically visible collateral flow to the target vessel distal to the occlusion, from ipsilateral or contralateral collaterals.
• •3. Because of the presence of moderate to severe tortuosity or stenosis in the collateral vessels, retrograde approach is not preferred at the investigator 's discretion.
• •4. Vessel tortuosity proximal to, or within, body of target occlusion which, in the opinion of the investigator, is not amenable to advancement of a microcatheter or Coronary Crossing System.