San Diego, California – November 1, 2026 – Medis Medical Imaging today welcomed the results of the randomized P4 trial, presented by Dr. Carlos Collet of the Cardiovascular Research Foundation, New York, at TCT 2026 and published simultaneously in The New England Journal of Medicine. P4 compared PCI planned and guided by coronary CT angiography (CCTA) with intravascular ultrasound (IVUS) guidance in 1,105 patients at 23 centers in Europe, the United States and Japan. In the CT-guided arm, Medis QAngio CT Research Edition was used to analyze plaque composition, including calcium, and to plan stent landing zones on the CT scan. It then brought the CT plan into the cath lab, displaying three-dimensional reconstructions synchronized with the C-arm angle. 

Target-vessel failure at 12 months, a composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target-vessel revascularization, occurred in 4.1% with CT guidance and 4.6% with IVUS guidance (risk difference −0.42 percentage points; 95% confidence interval, −2.82 to 1.99). The upper limit was below the prespecified non-inferiority margin of 4.5 percentage points (P<0.001); superiority could not be demonstrated. 

Procedures were about 17 minutes shorter with CT guidance (median 46 vs 63 minutes), and contrast volume during the invasive procedure was lower (median 150 vs 170 mL), with similar radiation dose (difference in medians, −2.91 Gy·cm2; 95% CI, −9.03 to 3.80).  

What CT Brings to the Procedure  

Quantitative CT analysis provides operators a view of the disease before the first wire is inserted: what the composition of the plaque is, how many lesions are present, which is the index lesion, and where should the stent land. It also helps to select optimal angiographic projections. In P4, operators in the CT-guided arm used advanced calcium-modification devices more often (9.2% vs 3.8%), and their procedures were still shorter. 

“P4 shows that, in appropriately selected patients, information we usually gather inside the artery during PCI can be obtained before catheterization, without an apparent loss of clinical efficacy,” said Dr. Collet, principal investigator of P4. “That supports moving PCI planning from the cath lab to the CT scan, and expands the role of CT from diagnosis to therapeutic guidance.” 

From Diagnosis to Intervention 

Medis is already focusing for 35 years on making cardiovascular images measurable, from quantitative coronary angiography to QFR® angiography-derived physiology, which holds a Class I recommendation in the 2024 ESC Guidelines for chronic coronary syndromes. Medis today also announced the release of its new product, QGuideCT®, which provides intuitive, interactive CT-derived lumen and plaque information, enabling the plan made on the CT scan to inform the treatment strategies, before and during the procedure. It has received FDA 510(k) clearance [K260523, October 5, 2026]. 

“Interventional cardiologists should not have to wait until a catheter is in the artery to understand the disease they are about to treat,” said Maya Barley, CEO of Medis Medical Imaging. “P4 shows that a plan built on CT holds up against intravascular imaging guidance, with shorter procedure time. With FDA clearance of Medis QGuideCT®, we bring the CT plan into US cath labs. Together with our third-generation angiography-derived physiology solution Medis QFR®, we provide a comprehensive solution from the diagnosis to treatment of coronary artery disease.” 

About P4 

P4 (Precise Procedural and PCI Plan; NCT05253677) is an investigator-initiated, international, randomized, open-label non-inferiority trial with blinded endpoint adjudication. It enrolled patients aged 18 to 80 years with chronic coronary syndrome or stabilized non-ST-segment elevation acute coronary syndrome and at least one lesion with more than 70% diameter stenosis and a CT-derived fractional flow reserve (FFRCT) of 0.80 or less.  Medis technology was used both to analyze plaque and plan the procedure on CT, and to bring CT-derived information into the cath-lab workflow.  

About Medis Medical Imaging 

For more than 35 years, Medis Medical Imaging has delivered advanced post-processing software for cardiovascular imaging. From MR and CT to X-ray- and angiography-based physiology, Medis equips clinicians with intuitive, scientifically validated tools that enhance diagnostic confidence and streamline workflows. In coronary artery disease, Medis connects diagnosis and intervention, from CT-based plaque and lesion analysis to angiography-derived physiology in the cath lab. Medis’ portfolio, including QFR®, supports clinicians in delivering high-quality, patient-centered cardiovascular care. 

Media contact: Sophie Desideri, Marketing Manager Diagnostic, Medis Medical Imaging, SDesideri@medisimaging.com