Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study

Coronary Artery Disease Clinical Trial

— Vortex-FIH  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674111
• Other study ID #: S2465
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: April 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)
The Vortex System is intended to provide temporary circulatory support in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria
Sweden	Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Australia,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Technical Success	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.	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).
Primary	Number of Participants With Clinical Success	No conversion to open heart surgery during the high-risk PCI procedure and no in-hospital mortality.	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).