NCT07515703

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

CARDIAC Trial: Coronary AtheRectomy and Drug Coated Ballon Intervention in All-comer Calcific Lesions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Calcific Lesions
• Plaque Modification Technique
• Drug Coated Balloon

Interventions

Type	Name	Description
DEVICE	IVL3003	management of severely calcified coronary artery with a DCB-only strategy following coronary modification systems (CMS) in patients with heavily calcified de novo coronary atherosclerotic disease.

Timeline

• Start date: 2019-03-01
• Primary completion: 2025-06-01
• Completion: 2026-03-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study