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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

DCB De Novo Stenosis PCI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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 receive 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 researchers 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 received 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Target Vessel Failure of de novo PCI

Time frame: 1 year

Number of patients with the composite endpoint (number of cardiovascular death, TV-MI, CD-TVR, angiographic restenosis)

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

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

Acronym: BOSS

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Feb 8, 2024
Registry last updated: Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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