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

De Novo Stenosis Clinical Trial

— BOSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247982
• Other study ID #: AOU Bologna
• Status: Recruiting
• Start date: November 6, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Gabriele Ghetti, MD
• Phone: +39512144475
• Email: gabriele.ghetti[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• DCB
• De Novo Stenosis
• Emergencies
• PCI

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Vessel Failure	Composite endpoint of: cardiovascular death, TV-MI, CD-TVR, angiographic restenosis	1 year