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OpenTrials
Completed

NCT Number: NCT07515703

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.

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Key information

Conditions

Coronary Calcific Lesions Color Vision Defects Cone Dystrophy Drug Coated Balloon Eye Diseases Eye Diseases, Hereditary Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Plaque Modification Technique Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Daniela Benedetto

Rome, 00133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVL3003

Device

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.

Other names: DRUG COATED BALLOON

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Acronym: CARDIAC

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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