Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone (NCT07038408) | Clinical Trial Compass
RecruitingNot Applicable
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
Estonia2,256 participantsStarted 2026-04-24
Plain-language summary
The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon \[DCB\] strategy with bail-out BioResorbable Scaffold \[BRS\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \[NSTEMI\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are:
DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy?
Participants will be followed at:
1. st FU visit - 1 month (in hospital)
2. nd FU visit - 6 months (telephone)
3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint
4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy
5. th FU visit - 730 days±30 days (telephone call) - 2Y
6. th FU visit - 1095 days±30 days (telephone call) - 3Y
7. th FU visit - 1460 days±30 days (telephone call) - 4Y
8. th FU visit- 1825 days±30 days (telephone call) - 5Y
Who can participate
Age range
18 Years – 68 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 aged ≥ 18 years ≤ 68 years
* Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm
* Maximum of 3 target lesions
* Maximal cumulative lesion length of all treated lesions 80 mm
* Signed informed consent for participation in the study
Exclusion Criteria:
* ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours
* Severe calcified lesions
* Bifurcations lesions with planned 2 device strategy
* Left-Main (LM) disease ≥ 50% diameter stenosis
* More than 3 target lesions
* Renal insufficiency with Glomerular Filtration Rate (GFR) \< 45 ml/min
* Life expectancy less than 1 year
* Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors
* Incapable of providing written informed consent
* Pregnant or breastfeeding women
* Under judicial protection, tutorship, or curatorship
* Participation in another trial
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 (TVF)
Timeframe: From enrollment to the end of treatment at 12 months