TCTR20231107001已完成1 期
Initial Evaluation of the KARDION CORY P4K System
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
The KARDION CORY P4K System Initial Evaluation Study demonstrated that the system is safe and performs as intended. No subjects experienced any of the primary outcome or secondary outcome measures and all cases were deemed a success, per protocol definition of procedure success. There were no adverse events reported for any of the subjects from index procedure through the 30-day follow up period
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 90 Years（—）
- 性别
- All
入选标准
- •Subject age at least 18 and less than or equal to 90 years at the time of screening
- •The subject has an LV ejection fraction of less than or equal to 50 percent (within 90 days of procedure) AND is at high-risk due to any of the following:
- •Unprotected left main coronary artery stenosis disease
- •Last remaining epicardial native coronary vessel
- •Significant three vessel disease (or two-vessel disease in a dominant left system)
- •The subject is an appropriate candidate for a PCI supported with a Mechanical Circulatory Support (MCS) System (e.g., non-emergent PCI, has been deemed to be suboptimal for cardiac surgery, requires hemodynamic support during the PCI procedure, does not have other diseases or therapies that restrict the use of an MCS System, and not expected to require cardiac support with an MCS System post-PCI procedure)
- •Confirmed access site vasculature greater than 5.5 mm as measured by CT or femoral duplex ultrasound
- •The subject is willing and able to comply with the protocol-specified treatment and follow-up evaluations
- •The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)
排除标准
- •Any prior coronary revascularization or revascularization attempt within 30 days prior to procedure
- •STEMI within 7 days prior to procedure - defined as new ST elevation at the J point in at least 2 contiguous leads of greater than or equal to 2 mm (0.2 mV) in men or greater than or equal to 1.5 mm (0.15 mV) in women in leads V2-V3 and/or of greater than or equal to 1 mm (0.1 mV) in other contiguous chest leads or the limb leads
- •Non-STEMI within 7 days prior to procedure with an elevated cardiac biomarker (CK-MB or Troponin greater than 1x ULN) without CK-MB or Troponin value down trending
- •Cardiac arrest within 7 days prior to procedure requiring CPR or defibrillation
- •Subjects with sustained ventricular tachycardia or repetitive/ prolonged non-sustained ventricular tachycardia or complex ventricular ectopy
- •Current left ventricular thrombus
- •Significant right heart failure (right ventricular fractional area change less than 35 percent on echocardiography)
- •Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization greater than 70mmHg
- •Combined cardiorespiratory failure
- •Presence of an atrial or ventricular septal defect (including post-infarct VSD)
- •Hypertrophic obstructive cardiomyopathy (HOCM), restrictive cardiomyopathy, or constrictive pericarditis
- •Cardiogenic shock (Cardiac index less than 1.8 l/min/meters squared) or pre-procedure use of inotropic or pressor therapy within 72 hours of the planned index procedure
- •Any use of mechanical circulatory support or an extracorporeal membrane oxygenation device within 14 days
- •Severe aortic valve insufficiency or stenosis or aortic valve replacement
- •Aortic vascular disease (i.e., aortic aneurysm, dissection, extreme tortuosity or calcification that creates additional risk to the placement of a MCS device)
- •Cerebrovascular Accident (CVA) within 180 days prior to procedure
- •Transient Ischemic Attack (TIA) within 90 days prior to procedure
- •Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count less than or equal to 100,000 or spontaneous INR greater than or equal to 1.5 or known fibrinogen less than or equal to 1.5 g/l)
- •Known hemoglobin diseases, such as sickle cell anemia, hemolytic anemia or thalassemia
- •Subject has evidence of an active infection on the day of the index procedure requiring oral or intravenous antibiotics
- •Active infection of the intended access site
- •Chronic renal dysfunction (eGFR less than 30 mL/min/1.73 meters squared) and/or patients requiring renal replacement therapy with dialysis
- •History of liver dysfunction with elevation of liver enzymes and bilirubin 3 times the upper limit of normal (ULN) within 90 days prior to procedure
- •Known or suspected severe pulmonary disease (e.g., forced expiratory volume (FEV)1 less than 1.0 l/s)
- •Allergy, sensitivity or intolerance to anesthesia, heparin, aspirin, adenosine diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia (HIT)
- •Any non-cardiac condition with life expectancy less than 3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer, etc.)
- •Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for greater than 24 hours with full neurologic recovery)
- •Decompensated heart failure requir
研究者
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