LNBLong-term Efficacy of DCB Treatment with Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in Young PCI Population
This clinical trial is investigating the long-term effectiveness of treating de-novo native coronary artery lesions in young patients undergoing percutaneous coronary intervention with Drug-Coated Balloons (DCB) and Bail-out Bare Metal Stents (BRS) compared to BRS treatment alone. The study's outcome measure is target-vessel failure, defined as a combination of cardiovascular death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization.
Angioplasty with DCB (bail-out BRS)
+ Angioplasty with BRS
Cardiovascular Diseases+2
+ Heart Diseases
+ Vascular Diseases
Treatment Study
Summary
Study start date: December 10, 2025
Actual date on which the first participant was enrolled.This study is focused on comparing two different treatment strategies for patients with new blockages in the heart's blood vessels. The study looks at using a technique called DCB treatment, which involves a special type of balloon to open blocked arteries, followed by a back-up treatment if needed, and compares it to another method called BRS treatment. The goal is to find out which method is more effective and safer for relatively young patients undergoing a procedure called PCI to improve blood flow to the heart. Understanding which treatment works better can help doctors make better decisions for their patients and potentially lead to better long-term heart health outcomes. Participants in this study will receive either the DCB treatment with a possible additional intervention or the BRS treatment. The study will track important outcomes such as whether the blood vessel remains open, if there are any heart attacks, or if additional procedures are needed within 12 months. Additionally, a smaller subset of participants will undergo detailed imaging to assess changes in the blood vessels over 13 months. The main goal is to measure how well the treatments prevent problems with the heart's blood vessels over time, and researchers will carefully monitor any side effects or complications that may arise.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2256 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 68 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives