Drug Coated Balloons Versus Drug-Eluting Stents for Severe Coronary Calcification After Optimal Calcium Modification Assessed by QFR PRECISE CAL Study

What this Trial Is About

Researchers are assessing whether drug coated balloons DCB work as well as drug eluting stents DES for patients with severe coronary calcification after optimal calcium modification. The study focuses on comparing major cardiovascular adverse events one year after treatment, differences in perioperative cardiovascular events, and changes in quantitative flow ratio QFR between the two treatments. Participants must have severe coronary calcification diagnosed by coronary angiography or intravascular ultrasound IVUS. This trial is interventional and randomized, sponsored by Shanghai Zhongshan Hospital. Participants will first undergo calcium modification using rotational atherectomy RA, excimer laser coronary angioplasty ELCA, or intravascular lithotripsy IVL. After these procedures, QFR will be measured, and only those with QFR above 0.8 will be randomized equally to receive either DCB or DES treatment. If a blood flow-restricting dissection occurs after DCB treatment, DES implantation will follow. The study includes telephone follow-ups at 1 and 6 months, with angiographic imaging at 12 months. During the study, participants will be monitored for major adverse cardiovascular events like cardiovascular death, target lesion revascularization, non-fatal stroke, and non-fatal myocardial infarction. Researchers will also track perioperative events such as side branch loss, coronary perforation, no-reflow or slow flow, and myocardial infarction as indicated by elevated cardiac markers. Follow-ups will assess the hearts blood flow using QFR one year after treatment. The total study duration extends through 2030, with ongoing safety and effectiveness assessments.

DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR