Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions
- Conditions
- DCBDe Novo StenosisPCI
- Registration Number
- NCT06247982
- Brief 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
- 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 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- 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)
- in-stent restenosis
- more than 1 year life expectancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Target Vessel Failure of de novo PCI 1 year Number of patients with the composite endpoint (number of cardiovascular death, TV-MI, CD-TVR, angiographic restenosis)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Azienda Ospedaliero-Universitaria di Bologna
🇮🇹Bologna, Italy