VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
- Conditions
- High-risk Percutaneous Coronary InterventionHeart Disease, Coronary
- Interventions
- Device: VITALYST System
- Registration Number
- NCT06132568
- Lead Sponsor
- Boston Scientific Corporation
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High Risk PCI Patients VITALYST System Patients undergoing non-emergent, high-risk percutaneous coronary interventions
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Columbia University Medical Center/New York Presbyterian Hospital
🇺🇸New York, New York, United States
Skane University Hospital
🇸🇪Lund, Sweden
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States