CompletedNot Applicable

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

Italy134 participantsStarted 2019-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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)

Timeframe: 2019-2026

Trial details

NCT IDNCT07515703

SponsorUniversity of Rome Tor Vergata

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-01

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