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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

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Study Aim

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.

What is being tested

Angioplasty with DCB (bail-out BRS)

+ Angioplasty with BRS

Procedure
Who is being recruted

Cardiovascular Diseases+2

+ Heart Diseases

+ Vascular Diseases

From 18 to 68 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2025
See protocol details

Summary

Principal SponsorCeric Sàrl
Study ContactDAVIDE CAPODANNO, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleMulti-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.
NCT07038408
Principal SponsorCeric Sàrl
Study ContactDAVIDE CAPODANNO, ProfessorMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2256 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Cardiovascular DiseasesHeart DiseasesVascular DiseasesMyocardial IschemiaAcute Coronary Syndrome

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
MeRes100 is used during the angioplasty (V2) for patients randomized in the BRS arm.

Group II

Experimental
Mozec SEB is used during the angioplasty (V2) for patients randomized in the DCB arm with bail-out BRS. If the operator considers the results as insufficient, the MeRes100 is also used in the patient.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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