Status:
COMPLETED
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
High-risk Percutaneous Coronary Intervention
Heart Disease, Coronary
Eligibility:
All Genders
18-89 years
Phase:
NA
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-PC...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06132568
Start Date
May 9 2024
End Date
January 17 2025
Last Update
June 22 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032