Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angio… (NCT06247982) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Bail-Out Stenting and Target-vessel Failure After Drug Coated Balloon Coronary percutaneouS Angioplasty for de Novo Lesions
Italy800 participantsStarted 2023-11-06
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Target Vessel Failure of de novo PCI
Timeframe: 1 year
Trial details
NCT IDNCT06247982
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna