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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07515703

Acronym

CARDIAC

Enrollment

134

Registered

2026-04-07

Start date

2019-03-01

Completion date

2026-03-01

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Calcific Lesions, Drug Coated Balloon, Plaque Modification Technique

Keywords

dcb, rotablation, ivl, orbital atherectomy

Brief 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.

Interventions

DEVICEIVL3003

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Inclusion criteria comprised patients aged ≥18 years with stable or unstable coronary artery disease (chronic coronary syndrome \[CCS\] or acute coronary syndrome \[ACS\]) eligible for percutaneous coronary intervention (PCI).

Exclusion criteria

* Angiographic

Design outcomes

Primary

Measure	Time frame	Description
procedural success, defined as <30% residual diameter stenosis with TIMI 3 flow, and target lesion failure (TLF), as a composite of cardiac death, target-vessel myocardial infarction (excluding periprocedural myocardial im)	2019-2026	The primary endpoints were: procedural success, defined as \<30% residual diameter stenosis with TIMI 3 flow, and target lesion failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction (excluding periprocedural myocardial infarction), and ischemia-driven target lesion revascularization (TLR), assessed at the last available follow-up. Secondary endpoints included major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and target vessel revascularization, as well as any revascularization.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026