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The Elevate™ System for Percutaneous Coronary Intervention
Study Summary
This trial looks at a device that can help people with heart disease by reducing risk during a coronary procedure.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have recently had a surgical procedure on your heart arteries.You have a condition where a procedure will be done on a specific artery in your heart without any protection.You have a condition called aortic stenosis, which affects the heart valve.You have a condition called cardiac tamponade, which affects your heart and can exclude you from participating in the study.You have a medical condition that is not related to the heart, and your life expectancy is less than 24 months.You have had a stroke or a mini-stroke in the past 6 months.You have a condition in your aorta (the main blood vessel in your body) that could make it risky for the device to be placed.
- Group 1: HR-PCI patients
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this clinical trial offer participation for individuals aged 50 or above?
"This research is recruiting individuals over the age of 18 and below 84 years old."
Are there still open slots for participants in this research?
"Clinicaltrials.gov points to the fact that this trial, which was introduced on March 1st 2023 and last modified February 3rd 2023, is no longer enrolling patients. Nevertheless, there are three other studies actively recruiting participants at this time."
Who qualifies as an acceptable participant in this experiment?
"This clinical trial seeks 15 participants, aged 18-84, who are scheduled for a high risk percutaneous coronary intervention. The necessary criteria include: having at least one stenotic lesion of the native artery or bypass graft; needing treatment on an unprotected left main coronary artery; possessing three-vessel disease (in LAD and LCX cases); requiring approval from a cardiac surgeon for PCI being the best option; and signing informed consent documents."
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