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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04674111




Registration number
NCT04674111
Ethics application status
Date submitted
14/12/2020
Date registered
19/12/2020

Titles & IDs
Public title
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Scientific 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)
Secondary ID [1] 0 0
S2465
Universal Trial Number (UTN)
Trial acronym
Vortex-FIH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)

Experimental: Vortex Feasibility Study (Vortex FIH) - 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)


Treatment: Devices: 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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Technical Success
Timepoint [1] 0 0
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 outcome [2] 0 0
Number of Participants With Clinical Success
Timepoint [2] 0 0
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).

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/04/2022
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Sweden
State/province [1] 0 0
Lund

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof. Antony Walton, MBBS
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04674111