coronary artery disease heart vessel disease
Conditions
Interventions
The device under clinical investigation is the IMPELLA® RECOVER® LP 2.5 System.
All patients undergo a high risk PCI under haemodynamic support of the IMPELLA
device.
Sponsors
Abiomed, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 15mmHg * hypotension (systolic BP 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary Safety Endpoint: Major Adverse Cardiac and Cerebral (MACCE) events defined as death, new myocardial infarction, target vessel revascularization, urgent coronary artery bypass grafting procedure or cerebral vascular accident during and up to 30 days post-device explant or hospital discharge, whichever is longer. 2. Primary Efficacy Endpoint: Freedom from Hemodynamic compromise during PCI procedure defined as: Mean Arterial Pressure (MAP) not falling below 60mm Hg for more than 10 minutes during the PCI procedure and additional pressor medication is not required. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Secundary Safety Endpoint: Other intra-procedural and peri-procedural adverse events (not listed under primary safety endpoint). 2. Secundary Efficacy Endpoint: a) Freedom from the following procedural-related events: i. Ventricular fibrillation ii. Tachycardia requiring electrical cardioversion b) Angiographic success defined as residual stenosis | — |
Countries
Netherlands
Outcome results
None listed