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

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Description

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.

Partecipants will recieve DCB PCI in de novo coronary stenosis. Treatments they'll be given should be:

DCB-only PCI
BOS PCI

Reaserchers 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

Study Overview

Start Date
November 6, 2023
Completion Date
December 31, 2024
Enrollment
800
Date Posted
February 8, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Azienda Ospedaliero-Universitaria di Bologna
Bologna 40138, Italy

Eligibility

Study Population
All de novo DCB PCI ≥ 18 years-old patients who meet inclusion/exclusion criteria.
Minimum Age (years)
18
Eligibility Criteria
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:

instent restenosis
more than 1 year life expectancy

Study Contact Info

Study Contact Name
Gabriele Ghetti, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
Drug coated balloon (DCB) percutaneous coronary intervention (PCI) has been shown to be as effective as last generation drug eluting stent (DES) PCI in many randomized trials. However a not negligible rate of patients must recieve a bail-out stenting (BOS) implantation after DCB-PCI. Only some studies report that the rate of MACE of these patients is higher than DCB-only or DES-PCI ones. Even if the BOS patients MACE rate is two times more than DCB-only or DES-only, due to the small amount of BOS patients in these studies there were not a statistically significant difference.

According to these evidence, BOSS study reaserchers will compare target vessel failure (TVF) rate in DCB-only and BOS group resulting from all vessel size de novo coronary artery stenosis DCB-PCI.

TVF as primary endpoint will include:

cardiovascular death
target vessel myocardial infarction (TV-MI). According to the third universal definition of myocardial infarction TV-MI will be considered a non fatal myocardial infarction with the evidence of myocardial necrosis in the vascular territory of previously treated target vessel
clinical driven target vessel revascularization (CD-TVR). CD-TVR will be considered as any repeat intervention of any segment of the target vessel, defined as the entire major coronary vessel proximal and distal to the target lesion.
Angiographic restenosis. It will considered in case of restenosis as either a > 50% loss of initial gain of the target lesion.

The trial will enroll all patients who recieved a de novo DCB-PCI from January 2020 to December 2023. The population will be divided into two groups:

DCB-only PCI
BOS PCI

Bail-out stenting will be done in case of high grade coronary dissection (> or equal to NHLBI grade C) or in case of > 30% recoil, according with International DCB Consensus.
NCTid (if applicable)
NCT06247982