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NCT06247982Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 30 Jan 2025

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
800 (estimated)
First submitted
31 Jan 2024
Start date
6 Nov 2023
Primary completion date
28 Jan 2025
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT number
NCT06247982

What you commit to

  • Study type: Observational
  • Planned participants: 800
  • From 6 Nov 2023 to the primary completion date, 28 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • in-stent restenosis
  • more than 1 year life expectancy

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero-Universitaria di Bologna
Coordinator of this site? Confirm its status
BolognaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.