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ACTIVE NOT RECRUITING
NCT06247982

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

Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

View on ClinicalTrials.gov

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

Official title: Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions: the BOSS Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2023-11-06

Completion Date

2025-01-28

Last Updated

2025-01-30

Healthy Volunteers

No

Locations (1)

Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy