Tests a scoring balloon for calcified heart artery narrowings before stenting
Tests the Naviscore scoring balloon to prepare calcified heart artery narrowings before stent placement.
Plain-language title generated from the registry record
Registry title: Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon
Key facts
- Where
- Bonheiden, Brussels, Libramont, Liège, Lodelinsart, and Mons, BelgiumSee the 6 sites
Where in Belgium
- ImeldaBonheiden, BelgiumNo longer taking part
- Hôpital Erasme - Cliniques universitaires de BruxellesBrussels, BelgiumNo longer taking part
- Hôpital VivaliaLibramont, BelgiumNo longer taking part
- CHR de la CitadelleLiège, BelgiumNo longer taking part
- Humani CHU Charleroi - ChimayLodelinsart, BelgiumNo longer taking part
- CHU HELORA site KennedyMons, BelgiumNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Mons
- Trial code
- NCT07650578
- Record updated
- 16 June 2026
- Original description
The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a drug-eluting stent. During percutaneous coronary interventions, the presence of calcified plaques in the heart arteries represents a major challenge because it can prevent stents from expanding fully. When a stent remains under-expanded, it significantly increases the long-term risk of arterial re-narrowing or blood clot formation. To optimize stent expansion, appropriate preparation of the diseased vessel section before stent insertion is a critical phase.Read full original descriptionShow less
MILOU: Minimize Intra Luminal Obstructive Underexpansion: A Prospective, Multi-Center Randomized Trial for the Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon
The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a drug-eluting stent. During percutaneous coronary interventions, the presence of calcified plaques in the heart arteries represents a major challenge because it can prevent stents from expanding fully. When a stent remains under-expanded, it significantly increases the long-term risk of arterial re-narrowing or blood clot formation. To optimize stent expansion, appropriate preparation of the diseased vessel section before stent insertion is a critical phase.
This study is a prospective, multi-center randomized trial designed to test the hypothesis that treating calcified coronary lesions with the Naviscore scoring balloon will achieve a better stent expansion and a larger final minimal stent area compared to standard lesion preparation using regular non-compliant balloons. Eligible participants will be randomized in a one-to-one ratio to one of these two lesion preparation strategies. For all included patients, standard drug-eluting stents will be deployed. The study will use intravascular ultrasound imaging to evaluate the final minimum area of the stent directly inside the treated artery at the site of the highest initial calcium burden. Participant health and clinical outcomes will be monitored for up to twelve months following the procedure.
Inclusion: Patient written consent is given, ≥18 years; A de novo lesion to be treated in a vessel between 2.5 and 4.0 mm; Moderate to heavily calcified lesions detected by coronary angiography on two orthogonal views, and confirmed by IVUS if the lesion can be crossed with the catheter.
Exclusion: Contraindication to dual antiplatelet therapy; Major surgical intervention planned within one year; Lesion responsible of a ST elevated Myocardial Infarction (STEMI); Patient <18 years old; Pregnant female; Thrombocytopenia (under 100 000); Significant left main lesion; Chronic total occlusion; Lesion in a graft; In-stent restenosis lesion.