Clinical trial NCT06132568: VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
Official title: VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High-risk Percutaneous Coronary Intervention
Heart Disease, Coronary
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2023-11-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success
timeFrame: Measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center/New York Presbyterian Hospital
state: New York
city: Lund
country: Sweden
facility: Skane University Hospital
Study officials:
References: