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

University of Rome Tor Vergata134 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

134

Conditions

Coronary Calcific Lesions Plaque Modification Technique Drug Coated Balloon

Interventions

IVL3003DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Daniela Benedetto

Rome, Rome, Italy

Outcomes

Primary Outcomes

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)

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.

Time frame: 2019-2026

Data from ClinicalTrials.gov

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