Visit ClinicalTrials.gov
To learn more about the Coronary IVL IDE Study.
A clinical study, also known as a clinical trial, is a research process that tests the safety and effectiveness of new healthcare products, medicines, and medical devices before they are approved for use. These trials are essential for developing new treatments and understanding diseases better, including how to fight and prevent them.
For patients with tough health conditions, clinical trials can offer new treatment options when other treatments haven't worked. This can provide hope and potentially life-saving solutions for people who have no other alternatives. Clinical trials help companies determine if new treatments are effective and safe.
To learn more about participating in a clinical trial, visit Abbott’s Clinical Trial webpage under "Get Education or Additional Information" at www.abbottclinicaltrials.com
Participating in a clinical study can help doctors learn more about diseases and test new treatments, like medications or medical devices, for conditions such as coronary artery disease. People who join these studies are volunteers who meet certain requirements. These studies are important because they help confirm if the new treatments are safe and effective.
Clinical studies help doctors find new ways to diagnose and treat diseases. They also improve our understanding of health and how to fight and prevent illnesses. By learning about these studies, you can see how important this research is for creating life-saving technologies, like new medical devices and medications. Once you know more, you might even decide to join a clinical study yourself.
As a participant in the study, you'll be looked after by highly trained doctors, nurses, and researchers who are dedicated to providing the best care. Every clinical study has a detailed plan that is reviewed by many experts to ensure it is as safe as possible. These experts come from federal health agencies and institutional review boards, which include doctors, scientists, and community members. They also monitor the study while it is happening and can stop it if they think it is unsafe. Your health will be closely watched throughout the study, and you can choose to leave the study at any time for any reason.
It is important that new medical treatments are tested on different groups of people who need them the most. Unfortunately, some groups are often not well-represented in clinical studies for heart disease. This lack of representation makes it harder to ensure everyone has access to life-saving treatments and to understand how different groups respond to new therapies.
Abbott is working to change this by making sure their research includes different groups of people. This helps improve care and makes sure that new treatments are available to everyone who needs them.
Your study doctor will give you all the information about the clinical study, and you'll have time to decide if you want to join. You can stop participating at any time without any penalties or losing any benefits you are entitled to.
If you decide to leave the study, the study doctor and staff will stop collecting new personal information from you. However, the information already collected will be kept to ensure the study results can be properly analyzed. The data collected up to the point you withdraw will still be part of the study results.
If you withdraw or are withdrawn from the study before it finishes, your study doctor will discuss any necessary follow-up with you.
Your study doctor can stop your participation in the study at any time, without your consent, for any reason. The sponsor of the study can also stop the study at any time.
If you have any questions about participating in the TECTONIC CAD IVL IDE study, please contact your study doctor.
Anyone who meets the study's eligibility criteria may be able to participate in the clinical study.
CL1028213 Rev. A
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