Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone

Launched by CERIC SÀRL · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat narrowed or blocked heart arteries using minimally invasive procedures. One method uses a special balloon coated with medicine (called a Drug-Coated Balloon or DCB) that helps keep the artery open, and if needed, a dissolvable scaffold (called a BioResorbable Scaffold or BRS) is placed to support the artery temporarily. The other method uses the dissolvable scaffold alone. The study wants to see if both methods work equally well in the short term (1 year) and long term (up to 5 years) for patients who have heart artery disease, including those with certain types of chest pain or mild heart attacks, and who are between 18 and 68 years old.

If you join the study, you will have heart artery treatment using one of these two methods and then be followed by doctors for up to five years through hospital visits and phone calls to check on your health and how well the treatment is working. To be eligible, you should have specific types of artery blockages that are not too complex, be within the age range, and be able to give informed consent. People with very severe artery problems, recent major heart attacks, severe kidney issues, or certain allergies would not be eligible. This study aims to find the best "leave nothing behind" approach—treating arteries effectively without leaving permanent metal stents inside—which could help improve long-term heart health.

Gender

ALL

Eligibility criteria

• 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