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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a device called the Naviscore Scoring Balloon for treating heavily calcified coronary arteries — is my calcium burden the kind that would typically be considered for this type of prep approach, and does my anatomy look like a fit for what they're studying?
2The trial is listed as 'not yet recruiting,' which means it hasn't started enrolling patients yet — do you have a sense of when it might open, and is it realistic for me to wait, or should we be moving forward with treatment now?
3The primary thing this trial is measuring is something called 'minimal stent area,' which relates to how well the stent opens up inside the artery — can you explain what that means for my situation and why it matters for my long-term outcomes?
4Since this is a device study with no assigned phase, what do we already know about the safety of scoring balloons like this one for calcified lesions, and are there any specific risks I should understand before deciding whether to discuss enrolling?
5What are the standard alternatives for preparing a calcified coronary lesion before stenting — such as rotational atherectomy or intravascular lithotripsy — and how would you compare those options to what this trial is evaluating?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Final Minimal Stent Area (MSA)
Timeframe: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.