Comparing Drug Eluting Balloon and Drug Eluting Stent to Treat Calcified Nodules in Coronary Artery Disease After Intravascular Lithotripsy

What this Trial Is About

Researchers are conducting an international, open-label, randomized controlled trial to compare two treatments for patients with new calcified nodules in their coronary arteries. The study investigates whether using a drug eluting balloon DEB after plaque modification with intravascular lithotripsy IVL is as effective or possibly better than using a drug eluting stent DES in terms of artery reopening and safety. This trial aims to address the lack of data on the safety and effectiveness of DEB in calcified lesions, which present challenges for stent placement and expansion. Participants receive percutaneous coronary intervention PCI involving intravascular lithotripsy to modify the calcified plaque, followed by either a drug eluting balloon or a drug eluting stent. They are randomly assigned to one of these two treatment groups. The study evaluates the late lumen loss and net lumen gain at 9 months to compare the vessels openness after treatment. Additional safety and efficacy outcomes, such as vessel dissection, thrombosis, and revascularization events, are assessed up to 24 months. During the trial, participants undergo intracoronary imaging to confirm the presence of calcified nodules and measure vessel diameter. Follow-up includes angiographic assessments and clinical evaluations at various time points up to 24 months. Researchers monitor safety events like myocardial infarction, bleeding, and cardiac death, as well as efficacy measures like minimal lumen diameter and restenosis rates. The total participation duration extends through the follow-up period to assess long-term treatment effects and safety.

DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.