Trials / Completed
CompletedNCT04674111
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2021-09-28
- Primary completion
- 2022-04-08
- Completion
- 2022-04-08
- First posted
- 2020-12-19
- Last updated
- 2024-04-24
- Results posted
- 2024-04-24
Locations
2 sites across 2 countries: Australia, Sweden
Source: ClinicalTrials.gov record NCT04674111. Inclusion in this directory is not an endorsement.