Trial Outcomes & Findings for Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study (NCT NCT04674111)
NCT ID: NCT04674111
Last Updated: 2024-04-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
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).
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Baseline characteristics by cohort
| Measure |
Vortex Feasibility Study (Vortex FIH)
n=5 Participants
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).
|
|---|---|
|
Age, Continuous
|
73.6 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Vortex Feasibility Study (Vortex FIH)
n=5 Participants
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).
|
|---|---|
|
Number of Participants With Technical Success
|
5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Vortex Feasibility Study (Vortex FIH)
n=5 Participants
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).
|
|---|---|
|
Number of Participants With Clinical Success
|
5 Participants
|
Adverse Events
Vortex Feasibility Study (Vortex FIH)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vortex Feasibility Study (Vortex FIH)
n=5 participants at risk
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).
|
|---|---|
|
Cardiac disorders
Hypotension
|
20.0%
1/5 • Through 72 hours post index procedure or at hospital discharge (whichever comes first)
|
Other adverse events
| Measure |
Vortex Feasibility Study (Vortex FIH)
n=5 participants at risk
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).
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|---|---|
|
Blood and lymphatic system disorders
Decrease in Hemoglobin
|
40.0%
2/5 • Number of events 2 • Through 72 hours post index procedure or at hospital discharge (whichever comes first)
|
|
Cardiac disorders
Arterial hemorrhage
|
20.0%
1/5 • Number of events 1 • Through 72 hours post index procedure or at hospital discharge (whichever comes first)
|
Additional Information
Amy Maurer, Director of Clinical Trials
Boston Scientific Corporation
Phone: 800-876-9960
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER