VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)

Completed · Not applicable

Conditions studied: High-risk Percutaneous Coronary Intervention, Heart Disease, Coronary

In brief

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).

Key facts

Study ID: NCT06132568
Run by: Boston Scientific Corporation
People needed: 15
Starts: 2024-05-09
Expected to finish: 2025-01-17
Last updated by the study team: 2025-06-22

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Piedmont Heart Institute — Atlanta, Georgia, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.