Status:
COMPLETED
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)
Eligibility Criteria
Inclusion
- A subject will be considered for enrolment in the study if all of the following inclusion criteria are met, provided no exclusion criteria are met:
- IC1. Subject provides signed informed consent. IC2. Subject is ≥ 18 years and \< 90 years of age.
- IC3 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 (≥ 50% diameter stenoses by visual estimate or total occlusion)
Exclusion
- A subject will be excluded from the study if any of the following exclusion criteria are met:
- EC1. Subject has had ST-elevation myocardial infarction (STEMI) within 24 hours.
- EC2. Subject has had pre-procedure cardiac arrest requiring cardiopulmonary resuscitation (CPR) within 24 hours of enrollment.
- EC3. Subject is in shock, defined as follows:
- Cardiac index (CI) \< 2.2 L/min/m2 and pulmonary capillary wedge pressure (PCWP) \> 15 mmHg -AND-
- Hypotension (systolic blood pressure \< 90 mmHg for \> 30 minutes) -OR-
- Need for supportive measures (i.e., inotropes or mechanical support) to maintain systolic blood pressure ≥ 90 mmHg and end organ hypoperfusion (cool extremities or urine \< 30 mL/hour and a heart rate \> 60 beats per minute) EC4. Subject has left ventricular mural thrombus. EC5. Subject has a prosthetic aortic valve. EC6. Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy).
- EC7. Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as ≥ 2+).
- EC8. Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery.
- EC9. Subject has peripheral vessel disease (PVD) preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the 16 Fr introducer sheath.
- Note: Minimum required vessel diameter is \> 5.5 mm. EC10. Subject has advanced renal dysfunction (AKIN Stage 3). EC11. Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin \> 3× upper limit of normal (ULN) or international normalization ratio (INR) ≥ 2.
- EC12. Subject has had a recent (within 1 month) stroke or TIA. EC13. 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.
- EC14. Subject has current or a history of heparin induced thrombocytopenia (HIT).
- EC15. Subject has uncorrected abnormal coagulation or platelet count ≤ 75,000/mm³ or INR ≥ 2.0.
- EC16. Subject has significant right heart failure (right atrial pressure \[RAP\] \> 15 mmHg, right ventricular stroke work index \[RVSWI\] \< 0.30 mmHg·L/m², pulmonary vascular resistance \[PVR\] \> 3.6 Woods units).
- EC17. Subject requires mechanical ventilation. EC18. Subject has an atrial or ventricular septal defect (including post-infarct ventricular septal defect \[VSD\]).
- EC19. Subject has left ventricular rupture. EC20. Subject has cardiac tamponade. EC21. Subject has severe pulmonary disease (FEV1 \< 1L). EC22. Subject has sustained or non-sustained ventricular tachycardia. EC23. Subject is breast feeding or is pregnant.
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04674111
Start Date
September 28 2021
End Date
April 8 2022
Last Update
April 24 2024
Active Locations (2)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
2
Skane University Hospital
Lund, Sweden, 222-42