Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study

Not Applicable

Completed

Conditions: Coronary Artery Disease

Interventions: Device: Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)

Registration Number: NCT04674111

Lead Sponsor: Boston Scientific Corporation

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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5

Inclusion Criteria

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 Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vortex Feasibility Study (Vortex FIH)	Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)	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)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success	Clinical success is measured during the procedure. Procedure time varies by patient and is measured from 1st vascular puncture for sheath insertion to vascular closure post sheath removal. Mean procedure time was 116.0 minutes (70.0 min, 148.0 max).	No conversion to open heart surgery during the high-risk PCI procedure and no in-hospital mortality.
Number of Participants With Technical Success	Technical success is measured during the procedure. Procedure time varies by patient and is measured from 1st vascular puncture for sheath insertion to vascular closure post sheath removal. Mean procedure time was 116.0 minutes (70.0 min, 148.0 max).	Successful delivery of the device to the correct anatomical position and successful operation and removal of the Vortex circulatory support system during high-risk PCI procedure.

Secondary Outcome Measures