Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in Side Branches of de Novo B… (NCT01485081) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in Side Branches of de Novo Bifurcation Lesions (DEBSIDE)
France52 participantsStarted 2012-05
Plain-language summary
The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native coronary arteries.
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 bifurcation lesions following the Medina classification except (0,0,1).
. Reference diameter main branch \>= 2.5 and ≤ 3.5 mm and side branch \>= 2.0 and ≤ 3.0 mm.
. Main branch lesion length ≤ 26mm and side branch lesion ≤ 6mm.
. Maximum two bifurcation lesions per patient on two different vessels with at least one lesion treated with the procedure described on the protocol (involving the Danubio).
. The side branch of the bifurcation involving the target lesion must be treated with the trial device (Danubio).
. During the index procedure, in case of:
. Successful sequential main branch and side branch predilatation with a conventional balloon providing good angiographic result (i.e. absence of dissection, TIMI \> III).
. The patient is at least 18 years of age.
Exclusion criteria
. De novo bifurcation lesion Medina (0,0,1).
. Left main bifurcation.
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
Late Lumen Loss (mm) in Side Branche (SB)
Timeframe: 6 months post-procedure (up to 26 weeks)