- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06247982
Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions (BOSS)
Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions: the BOSS Study
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
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gabriele Ghetti, MD
- Phone Number: +39512144475
- Email: gabriele.ghetti@aosp.bo.it
Study Locations
-
-
-
Bologna, Italy, 40138
- Recruiting
- Azienda Ospedaliero-Universitaria di Bologna
-
Contact:
- Gabriele Ghetti, MD
- Phone Number: +392144475
- Email: gabriele.ghetti@aosp.bo.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
DCB de novo PCI
All patients who recieved a de novo DCB PCI
|
BOS PCI
All patients who recieved a stent after DCB treatment of de novo coronary lesion beacuse of high grade dissection or recoil more than 30%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Vessel Failure
Time Frame: 1 year
|
Composite endpoint of: cardiovascular death, TV-MI, CD-TVR, angiographic restenosis
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gabriele Ghetti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOU Bologna
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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