Coronary Artery Disease
Conditions
Keywords
Mechanical circulatory support, High risk percutaneous coronary intervention (HR PCI)
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)
Interventions
DEVICETemporary 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).
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Prospective, open-label, single-arm feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Australia, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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)
Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System): The Vortex System is indicated to provide temporary circulatory support in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI). | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Vortex Feasibility Study (Vortex FIH) |
|---|---|
| Age, Continuous | 73.6 years STANDARD_DEVIATION 10.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 3 / 5 |
| serious Total, serious adverse events | 1 / 5 |
Outcome results
Primary
Number of Participants With Clinical Success
No conversion to open heart surgery during the high-risk PCI procedure and no in-hospital mortality.
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vortex Feasibility Study (Vortex FIH) | Number of Participants With Clinical Success | 5 Participants |
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.
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vortex Feasibility Study (Vortex FIH) | Number of Participants With Technical Success | 5 Participants |