At a glance
ClinicalIndex Comparison RecordN/ACompleted· 5 enrolled
Drug / intervention
Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A clinical study evaluating Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System) for Coronary Artery Disease. Completed, enrolled 5 participants across 2 sites in 2 countries.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesAustralia, Sweden
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartSep 2021
Primary CompletionApr 2022
TodayJul 2026
First PostedDec 19, 2020
Enrollment StartSep 28, 2021
Primary CompletionApr 8, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.5 years ago
Interventions
Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)device
The Vortex System is intended to provide temporary circulatory support in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).