Active — Not RecruitingNot Applicable

Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions

Italy800 participantsStarted 2023-11-06

Plain-language summary

The goal of this observational retrospective and prospective multicentric trial is to learn about the impact of bail-out stenting (BOS) after drug coated balloon (DCB) percutaneous coronary angioplasty (PCI) in de novo coronary stenosis.The main question to answer is: \- if BOS PCI leads to an higher rate of 1-year target vessel failure that DCB-only PCI. Participants will receive DCB PCI in de novo coronary stenosis. Treatments they\'ll be given should be: * DCB-only PCI * BOS PCI Researchers will compare DCB-only and BOS group to see if addictive stent implantation for DCB-PCI complication is relate to an higher rate of target vessel failure. Target vessel is the primary endpoint, defined as: * cardiovascular death * target vessel myocardial infarction * clinical driven target vessel revascularization * angiographic restenosis

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * De novo DCB PCI of at least one coronary artery * Hybrid PCI of bifurcation (main branch stent and side branch DCB) * Hybrid PCI of coronary artery with more than one stenosis (at least 10 mm of distance between edge of stent and DCB PCI segment) Exclusion Criteria: * in-stent restenosis * more than 1 year life expectancy

What they're measuring

Target Vessel Failure of de novo PCI

Timeframe: 1 year

Trial details

NCT IDNCT06247982

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-28

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