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

March 31, 2026 updated by: Daniela Benedetto, University of Rome Tor Vergata

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Rome
      • Rome, Rome, Italy, 00133
        • Daniela Benedetto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all patients with severe calcific coronary lesions treated with plaque modification and solo DCB PCI

Description

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 exclusion criteria included in-stent restenosis (ISR), lesions treated with a hybrid approach (DCB plus drug-eluting stent [DES]), residual stenosis >30%, or ≥ type C dissection after lesion preparation. Clinical exclusion criteria were hemodynamic instability and life expectancy <1 year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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.
2019-2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 25. Fezzi S, Scheller B, Cortese B, Alfonso F, Jeger R, Colombo A, et al. Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium. EuroIntervention. 2025 Apr 24;21(19):e1116-36. doi: 10.4244/EIJ-E-25-00021. Epub ahead of print. PMID: 40272160; PMCID: PMC12477504.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMS and DCB for CAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

is a multicenter registry where the choice of treatment is related with operators preference

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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