Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon

Starting soon · Not applicable

Conditions studied: Coronary Arterial Disease (CAD), Calcific Coronary Arteriosclerosis

In brief

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.

Key facts

Study ID

NCT07650578

Run by

University of Mons

People needed

200

Starts

2026-07-01

Expected to finish

2028-06-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient <18 years old.
• Pregnant female.
• Contraindication to dual antiplatelet therapy.
• Thrombocytopenia (under 100 000).
• Major surgical intervention planned within one year.
• Significant left main lesion.
• Chronic total occlusion.
• Lesion in a graft.
• In-stent restenosis lesion.
• Lesion responsible of a ST elevated Myocardial Infarction (STEMI)

Where it is running

• CHU - HELORA site Kennedy — Mons, Hainaut, Belgium
• Imelda — Bonheiden, Belgium
• Hôpital Erasme - Cliniques universitaires de Bruxelles — Brussels, Belgium
• Hôpital Vivalia — Libramont, Belgium
• CHR de la Citadelle — Liège, Belgium
• Humani CHU Charleroi - Chimay — Lodelinsart, Belgium
• INCCI Haerz Zenter — Luxembourg, Luxembourg
• Centro Hospitalar de Vila Nova de Gaia/Espinho — Vila Nova de Gaia, Portugal
• Hospital de Sant Pau — Barcelona, Spain
• Hospital Universitari de Bellvitge — Barcelona, Spain
• Hospital Puerta Del Mar — Cadiz, Spain
• Hospital San Pedro de Alcantara — Cáceres, Spain
• Hospital La Fe — Valencia, Spain
• Hospital Clínico Universitario de Valladolid — Valladolid, Spain

Full record on ClinicalTrials.gov

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