Plaque Modification and Drug Coated Balloons for Treatment of de Novo Calcific Coronary Lesions

The optimal management of severely calcified coronary artery disease remains challenging, particularly in the context of drug-coated balloon (DCB) angioplasty. This study aimed to evaluate the feasibility, safety, and mid-term clinical outcomes of a DCB-only strategy following coronary modification systems (CMS) in patients with heavily calcified de novo coronary atherosclerotic disease.

NCT Number	NCT07515703
Lead Sponsor	University of Rome Tor Vergata
Conditions	Coronary Calcific Lesions, Plaque Modification Technique, Drug Coated Balloon
Enrollment	134 participants
Start Date	2019-03-01
Primary Completion	2025-06-01 (estimated)
Study Completion	2026-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-07