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The investigator-initiated, MedStar Health-sponsored IMPROVE Trial evaluating the utility of Intravascular Ultrasound Imaging (IVUS) to guide optimization of percutaneous Coronary Intervention has enrolled more than 2,000 patients at over 80 sites in the U.S. and Europe.
For nearly 50 years, percutaneous coronary intervention has been the standard of care non-operative procedure of choice for many cases of coronary artery disease. Tools and technologies have advanced through the decades. MedStar Cardiovascular Research Network’s IMPROVE Trial is seeking definitive evidence to help more patients benefit from advanced imaging guidance.
More than a Million percutaneous coronary interventions (PCI, also known as angioplasty) are performed in the U.S. each year to open arteries blocked by coronary artery disease. Interventional cardiologists perform this minimally invasive procedure by threading a tiny tube through blood vessels until it reaches the blockage or lesion, most often caused by atherosclerosis (plaque buildup). About 90% of PCIs involve placing a mesh tube called a stent inside the blood vessel to help restore blood flow.
Traditionally, PCI is guided by a type of live X-ray called an angiogram to help physicians know where to place the stent. In the late 1980s, intravascular ultrasound (IVUS) gave us another imaging option. We can bounce sound waves off the artery’s walls using a tiny, catheter-based transducer instrument. This produces a more detailed image so we can better understand the size and characteristics of a lesion and the diameter of the blood vessel to precisely select the stent, decide its location, and improve patients’ outcomes.
Yet despite these advantages and small studies showing its benefits, IVUS is not often used in the U.S. While 50-70% of PCIs at MedStar Washington Hospital Center use IVUS, the nationwide average is closer to 10-20%.
IVUS can add some time to the procedure and some expense. The American Heart Association’s guidelines include IVUS as a Class IIa recommendation, meaning many physicians view it as optional despite evidence that it improves patient outcomes.
The IMPROVE Trial sets out to change all that by providing compelling data that IVUS benefits patients with complex CAD lesions.
A large, randomized trial of PCI imaging guidance.
IMPact on Revascularization Outcomes of IVUS Guided Treatment of Complex Lesions and Economic Impact (IMPROVE) is a prospective, single-blind trial that randomizes 2,500-3,000 participants at 80 U.S. and Western European sites to one of two groups.
The first group will receive coronary stent implantation guided by IVUS, and the second will have angiography-guided coronary stent implantation. All participants will have complex CAD lesions, meaning they are longer and more complicated than most. Participants will be monitored for two years to assess their outcomes.
Studying many patients with complex lesions in this randomized trial can help us answer the question of whether IVUS is superior to an angiogram for treating coronary lesions.
If IVUS is demonstrated to provide superior outcomes, we expect it will become a Class Ia recommendation. This strongest level of recommendation in the guidelines indicates a high level of evidence and a general agreement that a particular procedure should be performed for most patients. With more substantial recommendations often comes better reimbursement policies and increased access.
When the data comes in, we think there will no longer be any dispute about the value of IVUS in PCI. We expect to announce our results between spring and fall 2026.
Related reading: Study Reveals Exciting New Treatment for Cardiac Amyloidosis with Cardiomyopathy.
Helping more patients access leading care.
There are two main types of clinical trials. Commercial interests sponsor one type. These critical studies aim to approve a device, drug, or treatment that can be brought to market. We participate in many trials of this type.
At MedStar Health Research Institute, we also sponsor studies of our own. Investigator-initiated trials can lead to significant innovations that sometimes come before industry-sponsored advances. Our main goal isn’t to get new devices and drugs approved; we’re working to advance health in our community.
That critical distinction means that when we see an opportunity for improvement or a question that needs to be answered, we pursue it. IMPROVE is a hybrid: Investigator-instigated, co-sponsored by industry, and laser-focused on improving patient outcomes.
IMPROVE is an extensive study, even by industry standards. Collaboration between industry partners and more than 80 medical centers is a testament to our experience and aptitude in organizing and administering large trials. It’s possible because of our excellent team of dedicated associates and MedStar Health’s extensive network of centers.
Through studies such as IMPROVE, our patients get access to leading treatments. This unique benefit also enables our research to feature a diverse participant group, improving science and leading toward more equitable care.