Heart Disease, Coronary, High-risk Percutaneous Coronary Intervention
Conditions
Brief summary
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
Detailed description
The VITALYST EFS is a prospective, open-label, single-arm, multicenter feasibility study of the VITALYST System. The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI).
Interventions
DEVICEVITALYST System
The VITALYST System is a temporary ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively in hemodynamically stable subjects with severe coronary artery disease.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Subject provides signed informed consent. * Subject is ≥ 18 years and \< 90 years of age. * Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following: Unprotected left main or Last remaining vessel or Three vessel disease (at least one ≥ 50% diameter stenosis based on center's visual assessment in all three major epicardial territories) * Heart team, which must include a cardiac surgeon, agrees that HR-PCI is appropriate.
Exclusion criteria
* Subject has had STEMI within 72 hours with persistent elevation of cardiac enzymes. * Subject has had pre-procedure cardiac arrest requiring CPR within 24 hours of enrollment. * Subject has systolic blood pressure \< 90 mmHg with evidence of end organ hypoperfusion (e.g., cool extremities or urine \< 30 mL/hour). * Subject has had need for inotropes/vasopressors or mechanical circulatory support (including intra-aortic balloon pump) in the previous 24 hours to maintain a systolic blood pressure ≥ 90 mmHg. * Subject has left ventricular mural thrombus. * Subject has a prosthetic aortic valve. * Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy). * Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as \> 2+). * Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery. * Subject has PVD preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the introducer sheath as per the IFU. * Subject is not on dialysis and has creatinine \> 4 mg/dL. * Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin \> 3× ULN or INR ≥ 2. * Subject has had a recent (within 30 days) stroke or TIA. * Subject has known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors or nitinol. * Subject has current or a history of heparin induced thrombocytopenia. * Subject has uncorrected abnormal coagulation or platelet count ≤ 75,000/mm³ or INR ≥ 2.0. * Subject has significant right heart failure based on any one of the following criteria: RVSWI \< 0.30 mmHg·L/m² or PVR \> 3.6 Woods units or Pulmonary artery pulsatility index \< 1.85 * Subject requires non-elective mechanical ventilation. * Subject has an atrial or ventricular septal defect (including post-infarct VSD). * Subject has left ventricular rupture. * Subject has cardiac tamponade. * Subject has severe pulmonary disease (FEV1 \< 1L). * Subject has sustained or non-sustained ventricular tachycardia. * Subject is breast feeding or is pregnant. * Subject has infection of the proposed procedural access site or active systemic infection. * Subject has any condition that requires premature discontinuation of recommended antiplatelet and/or anticoagulant therapy before 90 days following the index procedure. * Any use of a mechanical circulatory support device within 14 days prior to the index procedure. * Staged PCI is planned within 90 days following device removal. * Subject is participating in another investigational drug or device study that has not reached its primary endpoint. * Subject has other disease condition(s) resulting in the subject being unsuitable for participation in the clinical trial (e.g., advanced malignancy with limited expected survival) * Subject has other disease condition(s) which the Investigator has determined may cause non-compliance to the study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success | Measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure | The primary endpoint consists of the composite endpoint of Clinical Success \[measured through 72 hours or hospital discharge (whichever comes first)\], which is defined as follows. * Technical Success: Successful delivery of the device to the correct anatomical position; and Successful operation and removal of the VITALYST circulatory support system * Absence of termination of revascularization procedure due to hemodynamic concern, or escalation to ECMO or other more intensive mechanical circulatory support device, or the use of vasopressors or inotropes * No conversion to open heart surgery * No mortality |
Countries
Sweden, United States
Outcome results
None listed