The VITALYST Early Feasibility Study (EFS) is a research study to test the VITALYST System, which helps support blood flow during a special heart procedure called high-risk percutaneous coronary intervention (HR-PCI). This procedure is used when there are blockages in the heart's blood vessels. The study is open-label, meaning everyone knows what treatment is given, and single-arm, meaning all participants receive the same treatment.
Eligibility for this study requires patients to be between 18 and 89 years old and need a non-emergency HR-PCI. People can't join if they've had a recent heart attack, have severe heart problems, or other serious health conditions. Participants will have to agree to the study rules and will be monitored by a team, including a heart surgeon.
- The study is conducted at multiple centers, so travel might be needed.
- There is no mention of compensation, but the focus is on safety and feasibility.
- There might be some risks, as with any medical intervention, so discussing with your doctor is important.