Stenting Versus Drug Eluting Balloons Only in Treatment of Coronary Bifurcation Lesion (ROBUST St… (NCT07552194) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Stenting Versus Drug Eluting Balloons Only in Treatment of Coronary Bifurcation Lesion (ROBUST Study)
272 participantsStarted 2026-06-02
Plain-language summary
The goal of this clinical trial is to learn immediate and follow up results of percutaneous treatment of coronary bifurcation lesion using drug eluting balloons (DEB) only in patients with chronic coronary syndrome (CCS). Researchers will compare endovascular treatment using solely DEB to stenting of coronary bifurcation lesion. The main questions it aims to answer are:
* What is immediate and follow up clinical and angiographic results of endovascular treatment of coronary bifurcation lesion using DEB in patients with CCS?
* Is efficacy and safety of endovascular treatment of coronary bifurcation lesion using DEB only in patients with CCS non inferior to compare stenting of aforementioned lesion which is contemporary recommended standard of care?
Participants will:
* Take prescribed medication before and after initial procedure during whole observation period (12 months)
* Visit the clinic at 1, 6 and 12 months after the initial procedure for checkup, noninvasive tests and control angiography at 12 months follow up
* Inform researchers about all adverse events that might be occur during follow up observation period
Who can participate
Age range
18 Years – 80 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:
* Patients with CCS with documented myocardial ischemia in area supplying by the target coronary artery, not older than 80 years and with an expected life expectancy of at least 1 year
* Patients with single- or multivessel disease and "true" (1.1.1; 1.1.0; and 0.1.1 according to the Medina classification) de novo bifurcation stenosis \> 50% and \<100% of the main coronary artery (excluding of the left main) or their large side branches.
* Both main and side branches should be ≥ 2.0 mm and ≤ 4.5 mm in diameter (according to Quantitative coronary angiography - QCA or intravascular imaging)
* Length of the main branch lesion should be no more than 30 mm
* The total length of the side branch should be no more than 7 cm, and the side branch lesion length should be no more than 10 mm
* Patients without hereditary coagulopathies
* With a recent (at least 3 months) history of acute coronary syndrome (ACS)
* Signed informed consent by patient to participate in the study
Exclusion Criteria:
* Patients with a single remaining artery supplying a large area of myocardium at risk, regardless of its caliber
* Over 80 years of age
* Bifurcation stenosis of the left main coronary artery and bifurcation lesions other than 1.1.1; 1.0.1, and 0.1.1 according to the Medina classification
* The difference between the proximal and distal reference diameter of the main artery is \> 1 mm
* Pregnancy or breastfeeding
* Severe valvular heart disease requiring surgical or percutan…
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
safety and efficacy
Timeframe: from enrollment to the end of observation at 12 months