NCT07038408Recruiting
Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone
Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2256 (estimated)
- First submitted
- 6 Jun 2025
- Start date
- 24 Apr 2026
- Primary completion date
- 30 Nov 2028
- Lead sponsor
- Ceric Sàrl
- Diseases
- Coronary artery disease
- NCT number
- NCT07038408
What you commit to
- Study type: Interventional
- Planned participants: 2256
- From 24 Apr 2026 to the primary completion date, 30 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours
Other illness
- Left-Main (LM) disease ≥ 50% diameter stenosis
- Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors
Lab values
- Renal insufficiency with Glomerular Filtration Rate (GFR) \< 45 ml/min
Other
- Severe calcified lesions
- Bifurcations lesions with planned 2 device strategy
- More than 3 target lesions
- Life expectancy less than 1 year
- Incapable of providing written informed consent
- Pregnant or breastfeeding women
- Under judicial protection, tutorship, or curatorship
- Participation in another trial
Who the study is looking for
- 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
Age in the registry: 18 years to 68 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Põhja-Eesti Regionaalhaigla Coordinator of this site? Confirm its status | Tallinn | Estonia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.