NL-OMON30115尚未招募不适用
PROTECT I: A Prospective Feasibility Trial Investigating the use of the IMPELLA® RECOVER® LP 2.5 System in Patients Undergoing High Risk PCI IDE Number: G050017 - PROTECT I
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Abiomed, Inc
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria
- •For inclusion in the study, subjects must fulfill all of the following criteria:
- •1. Signed Informed Consent.
- •2. Patient is indicated for a NON emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft.
- •3. Age Eligible (40 * Age * 80)
- •4. Patient has no child bearing potential or has a negative pregnancy test within 7 days prior to treatment.
- •5. Patient presents with Left Ventricular Ejection Fraction (LVEF) *35%
- •Subjects must also meet at least one of the following criteria:;a) Intervention on the last patent coronary conduit
- •b) Intervention on an unprotected left main coronary artery
排除标准
- •Exclusion Criteria
- •1. ST Myocardial Infarction within 7 days
- •2. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR.
- •3. Subject is in cardiogenic shock defined as:
- •* CI < 2.2 l/min/m2 and PCWP > 15mmHg
- •* hypotension (systolic BP < 90 mmHg for > 30 minutes or the
- •need for supportive measures to maintain a systolic BP of
- •greater than or equal to 90 mmHg) AND end organ
- •hypoperfusion (cool extremities OR [a urine output of < 30
- •ml/hour AND a HR > 60 BPM]).
- •4. Mural thrombus in the left ventricle.
- •5. The presence of a mechanical aortic valve or heart constrictive device.
- •6. Documented presence of aortic stenosis (aortic stenosis graded as
- •* +2 equivalent to an orifice area of 1.5cm2 or less).
- •7. Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as * +2).
- •8. Severe peripheral arterial obstructive disease that would preclude RECOVER LP 2.5 System device placement.
- •9. Abnormalities of the aorta that would preclude surgery, including aneurysms and extreme tortuosity or calcifications.
- •10. Subject with renal dysfunction (creatinine * 3.5mg/dL).
- •11. Subject has history of debilitating liver dysfunction with elevation of liver enzymes and bilirubin levels to * 3x ULN or INR (Internationalized Normalized Ratio) * 2.
- •12. Subject has severe pulmonary disease (FEV1*1, etc.).
- •13. Subject has uncorrectable abnormal coagulation parameters
- •(defined as platelet count *75,000/mm3 or INR *2.0 or Fibrinogen * 1.50 g/l.)
- •14. Subject has sustained or nonsustained ventricular tachycardia.
- •15. Active systemic infection.
- •16. History of recent (within 3 months) stroke or TIA.
- •17. Allergy or intolerance to heparin, aspirin, clopidogrel or contrast media.
- •18. Patients with documented heparin induced thrombocytopenia.
- •19. Participation in the active follow-up phase of another clinical study of an investigational drug or device.
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