Coronary Arterial Disease (CAD)MILOUNCT07650578

Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon

A study testing Scoring Balloon PTCA Catheter and Non-Compliant (NC) Angioplasty Balloon in people with Coronary Arterial Disease (CAD) and Calcific Coronary Arteriosclerosis, run by University of Mons at 14 sites in 4 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Arterial Disease (CAD), Calcific Coronary Arteriosclerosis
What is being tested?: Scoring Balloon PTCA Catheter and Non-Compliant (NC) Angioplasty Balloon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 14 sitesin 4 countries
Study dates: Jul 2026to Jun 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

Chronic total occlusion.
Lesion in a graft.
In-stent restenosis lesion.
Lesion responsible of a ST elevated Myocardial Infarction (STEMI)

Trial locations and contacts

14 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Stéphane Carlier, MD, PhD contact

+3265373381

stephane.carlier@umons.ac.be

Country

City, postcode or hospital

14 sites in 4 countries

Belgium6 sites

Imelda
Bonheiden, 2820
Hôpital Erasme - Cliniques universitaires de Bruxelles
Brussels, 1070
Gabriela Flores Vivian, MD, +3225554290, g.floresvivian@hubruxelles.be
Gabriela Flores Vivian, MD
Hôpital Vivalia
Libramont, 6800
Chadi Ghafari, MD, PhD, +32483128996, chadi_ghafari@yahoo.com
Chadi Ghafari, MD, PhD
CHR de la Citadelle
Liège, 4000
Georges Saad, MD, +3243217155, georges.saad@citadelle.be
Sophie Jacquet, +3243217820, rc-cardio@citadelle.be
Humani CHU Charleroi - Chimay
Lodelinsart, 6042
Cellule de recherche clinique, +32071920545, cellule.recherche.clinique@humani.be
Mohamed Ben Yedder, MD
CHU - HELORA site Kennedy
Mons, Hainaut, 7000
Stéphane Carlier, MD, PhD, +3265373381, stephane.carlier@umons.ac.be
Stéphane Carlier, MD, Phd

Other trials in Belgium

Spain6 sites

Hospital de Sant Pau
Barcelona, 08025
Estefanía Fernández-Peregrina, MD, +34628839525, efernandezpe@santpau.cat
Elena Jiménez Xarrié, +34628839525
Hospital Universitari de Bellvitge
Barcelona, 08901-08908
Andrea Ruberti, +34 932 60 75 00, andreaalbertoruberti@bellvitgehospital.cat
Andrea Ruberti, MD
Hospital San Pedro de Alcantara
Cáceres, 10003
Juan Carlos Rama, +34615611413, ramamerchan@hotmail.com
Juan Carlos Rama, MD
Hospital Puerta Del Mar
Cadiz, 11009
Alejandro Gutiérrez-Barrios, MD, +34 620688877, aleklos@hotmail.com
Alejandro Gutiérrez-Barrios, MD
Hospital La Fe
Valencia, 46026
Jorge Sanz Sanchez, +34 660360598, sjorge4@gmx.com
Ines Roche Fortea, ines_roche@islafe.es
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Ignacio J Amat Santos, MD, +34983420000 ext. 86571, ijamat@gmail.com
Carlos Baladrón Zorita, +34983 42 00 00 ext. 86571, cbaladron@icicor.es

Other trials in Spain

Luxembourg1 site

INCCI Haerz Zenter
Luxembourg, 1210
Bruno Pereira, MD, + 352 691 86 31 86, dr.pereira@pt.lu
Bruno Pereira, MD

Other trials in Luxembourg

Portugal1 site

Centro Hospitalar de Vila Nova de Gaia/Espinho
Vila Nova de Gaia, 4430-999
Alberto Rodrigues, +351919589753, rodrigues.jal@gmail.com
Alberto Rodrigues, MD

Other trials in Portugal

About this study

Official title: 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.

Read the detailed description

Percutaneous transluminal coronary angioplasty (PTCA) is the main technique in percutaneous coronary intervention (PCI). It aims to restore coronary blood flow by mechanically enlarging a stenotic arterial segment through controlled balloon inflation within the vessel lumen. The acute luminal gain with balloon angioplasty is the result of multiple mechanisms, ranging from percolation and longitudinal redistribution of atheroma, to plaque fracture, and overstretching of the vessel wall, often accompanied by intimal tearing and medial dissection. While contemporary drug-eluting technologies have significantly improved long-term clinical outcomes, fibrocalcified atheromatous intracoronary plaques still present a significant challenge for stent crossing and optimal deployment.

Research has demonstrated that suboptimal stent expansion and malapposition are significant contributing factors to restenosis and stent thrombosis rates, regardless of the type of stent used. Intravascular imaging registries have identified that twenty to thirty percent of deployed stents remain under-expanded or malapposed in daily clinical practice. Severe coronary calcification can make it difficult to deliver devices and can limit the expansion of stents, which can result in suboptimal improvement in blood flow and an increased risk of adverse events, including target lesion failure. Furthermore, heavily calcified lesions have been found to be associated with higher rates of vessel dissection, perforation and impaired anti-proliferative drug delivery, resulting from the mechanical barrier of the calcium burden.

In order to achieve successful stent deployment, optimal preparation of fibro-calcific lesions is essential and involves a number of plaque modification strategies. Focused force angioplasty is a procedure that targets specific locations of the plaque, focusing inflation forces on the area to induce localized stress and facilitate cracking. It is crucial to ensure that the pre-dilatation balloon is correctly sized to maximise safety by minimising the risk of advanced coronary perforation or severe medial damage. It is imperative that sizing compliance chart data is followed rigorously, as compliant balloons can display an unpredictable non-linear expansion behaviour at higher pressures, whereas non-compliant balloons maintain a stable volume, concentrating their dilating force directly at the calcified site up to their rated burst pressure. Semi-compliant pre-dilatation balloons often expand asymmetrically in resistant lesions, increasing the risk of edge dissections. The sizing and performance of scoring devices and non-compliant balloons remains limited in contemporary clinical literature. This randomised trial is designed to evaluate the post-market clinical performance, safety and comparative effectiveness of the Naviscore scoring balloon catheter manufactured by iVascular.

Conditions: Coronary Arterial Disease (CAD), Calcific Coronary Arteriosclerosis
Being tested: Scoring Balloon PTCA Catheter, Non-Compliant (NC) Angioplasty Balloon
Keywords: Percutaneous Coronary Intervention, Lesion Preparation, Scoring Balloon, Intravascular Ultrasound, Stent Expansion, Coronary Artery Calcification

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Scoring Balloon PTCA CatheterDevice
Also called Naviscore Scoring Balloon
Percutaneous coronary preparation of calcified coronary stenosis using the rapid exchange Naviscore scoring balloon catheter before drug-eluting stent deployment. The device incorporates an over-the-balloon metallic nitinol element designed to focally concentrate dilation forces, minimizing balloon slippage and scoring the atheromatous plaque at lower pressures to facilitate optimal stent expansion. Sizing is based on a 0.8:1 to 1:1 ratio relative to the reference lumen. Operators must execute a specific sequence of inflating the scoring balloon to nominal pressure, fully deflating it, mobilizing it within the lesion, and reinflating it, repeated three to four times across the target segment to ensure multi-focal plaque disruption before stenting.
Non-Compliant (NC) Angioplasty BalloonDevice
Also called Conventional PTCA Balloon
Conventional non-compliant (NC) PTCA balloon catheter used for standard lesion pre-dilatation according to routine clinical practice, inflated below the rated burst pressure without parallel guidewires in place.

Study groups in NCT07650578
Study group	Role	What they receive
Standard NC group	Active comparator	Lesion preparation of calcified coronary stenosis performed using standard non-compliant (NC) balloons. Balloons are sized according to a 0.8:1 to 1:1 ratio relative to the reference lumen and inflated below the rated burst pressure. To maintain a strict comparison and eliminate any scoring effect, no parallel guidewire is allowed in the target vessel during inflation. Receives: Device: Non-Compliant (NC) Angioplasty Balloon
Naviscore group	Experimental	Lesion preparation of calcified coronary stenosis performed using the Naviscore scoring balloon catheter before drug-eluting stent implantation. The device is sized according to a 0.8:1 to 1:1 ratio relative to the reference lumen. To maximize the plaque-modification effect of the external nitinol wires, a mandatory mechanical mobilization sequence must be performed: the balloon is inflated to nominal pressure, fully deflated, mobilized within the lesion, and reinflated. This specific sequence must be repeated 3 to 4 times across the target segment. Receives: Device: Scoring Balloon PTCA Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Final Minimal Stent Area (MSA)
The minimal stent area (MSA) will be measured in square millimeters by intravascular ultrasound (IVUS) after final procedural optimization. The primary comparison will evaluate the MSA specifically at the exact site of the initial heaviest calcium burden to demonstrate the superiority of the Naviscore scoring balloon over standard non-compliant (NC) balloons.
Measured: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.

Secondary outcomes (14)

Minimal Stent Area (MSA) Across the Entire Stented Segment
The minimal stent area (MSA) in square millimeters measured across the entire length of the deployed segment using intravascular ultrasound (IVUS) pullbacks to evaluate overall stent expansion expansion
Measured: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
Stent Eccentricity at the Site of the Minimal Stent Area
Stent eccentricity index calculated as the ratio of the minimum stent diameter over the maximum stent diameter, measured via intravascular ultrasound (IVUS) at the exact cross-section of the minimal stent area segment
Measured: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
Stent Eccentricity at the Initial Heaviest Calcium Burden Site
Stent eccentricity index calculated as the ratio of the minimum stent diameter over the maximum stent diameter, measured via intravascular ultrasound (IVUS) specifically at the cross-section matching the initial heaviest baseline calcium plaque burden
Measured: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
Device Success Rate
Percentage of cases achieving successful delivery of the assigned pre-dilatation balloon, complete inflation with adequate lesion preparation, and the absolute absence of vessel rupture or advanced coronary perforation categorized by the Ellis classification
Measured: During the index percutaneous coronary intervention (PCI) procedure
Major Adverse Cardiac Events (MACE) Rate
Percentage of participants experiencing Major Adverse Cardiac Events (MACE), defined as a composite clinical endpoint of myocardial infarction, stroke or transient ischemic attack, or cardiac death
Measured: At 1 and 12 months post-procedure
Target Lesion Failure (TLF)
Percentage of participants experiencing Target Lesion Failure (TLF), defined as a composite of cardiac death, target-vessel myocardial infarction defined according to ARC-2 criteria, or clinically indicated Target Lesion Revascularization
Measured: At 1 and 12 months post-procedure
Target Vessel Failure (TVF)
Defined as a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated Target Vessel Revascularization (TVR).
Measured: At 1 and 12 months post-procedure
Clinically Indicated Target Lesion Revascularization (TLR)
Percentage of participants requiring a repeat percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) driven by a recurrent narrowing inside the originally treated target lesion segment (including the stent and its five-millimeter proximal and distal borders), which is accompanied by clinical symptoms of ischemia or objective functional evidence of myocardial ischemia.
Measured: At 1 and 12 months post-procedure
Clinically Indicated Target Vessel Revascularization (TVR)
Percentage of participants requiring any repeat percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in any segment of the originally treated target vessel, driven by angiographic restenosis or disease progression, and accompanied by clinical symptoms of ischemia or objective functional evidence of myocardial ischemia.
Measured: At 1 and 12 months post-procedure
Procedural Success Rate
Percentage of cases achieving Device Success (successful delivery of the assigned balloon and complete inflation with adequate lesion preparation) combined with a final residual stenosis of less than thirty percent as measured by quantitative coronary angiography (QCA) and a final Thrombolysis in Myocardial Infarction (TIMI) grade 3 flow, without the occurrence of in-hospital Major Adverse Cardiac Events (MACE).
Measured: During the index percutaneous coronary intervention (PCI) procedure and until hospital discharge (up to 24 hours post-procedure).
Final Residual Stent Underexpansion
Evaluation of the final residual underexpansion of the drug-eluting stent after deployment and high-pressure post-dilatation, measured in millimeters using motion-corrected X-ray stent visualization software (StentBoost or equivalent stent enhancement method) in two orthogonal views without contrast.
Measured: At the end of the index percutaneous coronary intervention (PCI) procedure (immediate post-stenting optimization).
Final Stent Diameter Stenosis
The final percentage of stent diameter stenosis evaluated by quantitative coronary angiography (QCA) at the index procedure after final stent deployment and post-dilatation optimization.
Measured: At the end of the index percutaneous coronary intervention (PCI) procedure.
Rate of Procedural Complications
The cumulative rate of procedure-related complications during the index procedure, defined as a composite of cardiac death, acute myocardial infarction, emergency coronary artery bypass graft surgery (CABG), coronary artery perforation (Ellis classification), and cardiac tamponade directly related to the use of the Naviscore scoring balloon or the regular non-compliant (NC) balloon.
Measured: During the index percutaneous coronary intervention (PCI) procedure (immediate intra-procedural period).
Procedural Cost-Effectiveness
Evaluation of the procedural cost-effectiveness of using the Naviscore scoring balloon compared to standard non-compliant (NC) balloons for calcified lesion preparation, calculated by factoring device costs, overall material utilisation during the intervention, procedure duration, and the need for bailout additional plaque-modification tools or complementary high-pressure devices.
Measured: During the index percutaneous coronary intervention (PCI) procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2026Jun 2028

First posted16 Jun 2026
Study startJul 2026 (estimated)
Primary completionJun 2027 (estimated)
Study completionJun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07650578
Sponsor's protocol ID: 009
Other IDs: Unrestricted grant
Acronym: MILOU
Status last verified: Jun 2026
First submitted: 10 Jun 2026
Last updated: 16 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The individual participant data (IPD) that underlie the results reported in this publication, including the final minimal stent area (MSA) measurements, procedural success data, and relevant clinical adverse event records, will be shared. Supporting documents, including the study protocol, statistical analysis plan, and informed consent forms, will be provided to support the interpretation of the IPD. All data shared will be de-identified to maintain participant confidentiality in accordance with GDPR requirements.

Publications

Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
PubMed 29897428
Jujo K, Saito K, Ishida I, Kim A, Suzuki Y, Furuki Y, Ouchi T, Ishii Y, Sekiguchi H, Yamaguchi J, Ogawa H, Hagiwara N. Intimal disruption affects drug-eluting cobalt-chromium stent expansion: A randomized trial comparing scoring and conventional balloon predilation. Int J Cardiol. 2016 Oct 15;221:23-31. doi: 10.1016/j.ijcard.2016.07.002. Epub 2016 Jul 4.
PubMed 27400292
Riley RF, Patel MP, Abbott JD, Bangalore S, Brilakis ES, Croce KJ, Doshi D, Kaul P, Kearney KE, Kerrigan JL, McEntegart M, Maehara A, Rymer JA, Sutton NR, Shah B. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions. J Soc Cardiovasc Angiogr Interv. 2024 Jan 31;3(2):101259. doi: 10.1016/j.jscai.2023.101259. eCollection 2024 Feb.
PubMed 39132214
Barbato E, Gallinoro E, Abdel-Wahab M, Andreini D, Carrie D, Di Mario C, Dudek D, Escaned J, Fajadet J, Guagliumi G, Hill J, McEntegart M, Mashayekhi K, Mezilis N, Onuma Y, Reczuch K, Shlofmitz R, Stefanini G, Tarantini G, Toth GG, Vaquerizo B, Wijns W, Ribichini FL. Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group. Eur Heart J. 2023 Nov 1;44(41):4340-4356. doi: 10.1093/eurheartj/ehad342.
PubMed 37208199
Zhang M, Matsumura M, Usui E, Noguchi M, Fujimura T, Fall KN, Zhang Z, Nazif TM, Parikh SA, Rabbani LE, Kirtane AJ, Collins MB, Leon MB, Moses JW, Karmpaliotis D, Ali ZA, Mintz GS, Maehara A. Intravascular Ultrasound-Derived Calcium Score to Predict Stent Expansion in Severely Calcified Lesions. Circ Cardiovasc Interv. 2021 Oct;14(10):e010296. doi: 10.1161/CIRCINTERVENTIONS.120.010296. Epub 2021 Oct 19.
PubMed 34665658
Mangieri A, Nerla R, Castriota F, Reimers B, Regazzoli D, Leone PP, Gasparini GL, Khokhar AA, Laricchia A, Giannini F, Casale F, Bezzeccheri A, Briguori C, Colombo A. Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial. Catheter Cardiovasc Interv. 2023 Mar;101(4):798-805. doi: 10.1002/ccd.30603. Epub 2023 Feb 25.
PubMed 36841945
Penaranda AS, Peregrina EF, Kockar MJ, Del Blanco BG, Romani S, Moreiras JM, Bermudez EP, Rodrigues A, Ojeda S, Lopez NG, Regueiro A, Frutos AS. New scoring balloon to treat moderate-to-severe calcified coronary lesions. The first-in-man Naviscore study. REC Interv Cardiol. 2025 Feb 3;7(2):91-98. doi: 10.24875/RECICE.M24000484. eCollection 2025 Apr-Jun.
PubMed 40438639

Interested in taking part?

Stéphane Carlier, MD, PhD

+3265373381

stephane.carlier@umons.ac.be

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Coronary Arterial Disease (CAD) trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07650578
Acronym / sponsor ID: MILOU / 009
Conditions: Coronary Arterial Disease (CAD), Calcific Coronary Arteriosclerosis
Keywords: Percutaneous Coronary Intervention, Lesion Preparation, Scoring Balloon, Intravascular Ultrasound, Stent Expansion, Coronary Artery Calcification
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: University of MonsUniversity, hospital or other
Collaborators: iVascular S.L.U.
Study start: Jul 2026 (estimated)
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2028 (estimated)
First posted: 16 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard NC group	Active comparator	Device: Non-Compliant (NC) Angioplasty BalloonLesion preparation of calcified coronary stenosis performed using standard non-compliant (NC) balloons. Balloons are sized according to a 0.8:1 to 1:1 ratio relative to the reference lumen and inflated below the rated burst pressure. To maintain a strict comparison and eliminate any scoring effect, no parallel guidewire is allowed in the target vessel during inflation.
Naviscore group	Experimental	Device: Scoring Balloon PTCA CatheterLesion preparation of calcified coronary stenosis performed using the Naviscore scoring balloon catheter before drug-eluting stent implantation. The device is sized according to a 0.8:1 to 1:1 ratio relative to the reference lumen. To maximize the plaque-modification effect of the external nitinol wires, a mandatory mechanical mobilization sequence must be performed: the balloon is inflated to nominal pressure, fully deflated, mobilized within the lesion, and reinflated. This specific sequence must be repeated 3 to 4 times across the target segment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (10 listed)

Patient <18 years old.
Pregnant female.
Contraindication to dual antiplatelet therapy.
Thrombocytopenia (under 100 000).
Major surgical intervention planned within one year.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Scoring Balloon PTCA CatheterAlso: Naviscore Scoring BalloonPercutaneous coronary preparation of calcified coronary stenosis using the rapid exchange Naviscore scoring balloon catheter before drug-eluting stent deployment. The device incorporates an over-the-balloon metallic nitinol element designed to focally concentrate dilation forces, minimizing balloon slippage and scoring the atheromatous plaque at lower pressures to facilitate optimal stent expansion. Sizing is based on a 0.8:1 to 1:1 ratio relative to the reference lumen. Operators must execute a specific sequence of inflating the scoring balloon to nominal pressure, fully deflating it, mobilizing it within the lesion, and reinflating it, repeated three to four times across the target segment to ensure multi-focal plaque disruption before stenting.	Device	Naviscore group
Non-Compliant (NC) Angioplasty BalloonAlso: Conventional PTCA BalloonConventional non-compliant (NC) PTCA balloon catheter used for standard lesion pre-dilatation according to routine clinical practice, inflated below the rated burst pressure without parallel guidewires in place.	Device	Standard NC group

Primary outcome

Final Minimal Stent Area (MSA)
Time frame: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.
The minimal stent area (MSA) will be measured in square millimeters by intravascular ultrasound (IVUS) after final procedural optimization. The primary comparison will evaluate the MSA specifically at the exact site of the initial heaviest calcium burden to demonstrate the superiority of the Naviscore scoring balloon over standard non-compliant (NC) balloons.

14 secondary outcomes

Minimal Stent Area (MSA) Across the Entire Stented Segment
Time frame: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
Stent Eccentricity at the Site of the Minimal Stent Area
Time frame: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
Stent Eccentricity at the Initial Heaviest Calcium Burden Site
Time frame: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
Device Success Rate
Time frame: During the index percutaneous coronary intervention (PCI) procedure
Major Adverse Cardiac Events (MACE) Rate
Time frame: At 1 and 12 months post-procedure
Target Lesion Failure (TLF)
Time frame: At 1 and 12 months post-procedure
Target Vessel Failure (TVF)
Time frame: At 1 and 12 months post-procedure
Clinically Indicated Target Lesion Revascularization (TLR)
Time frame: At 1 and 12 months post-procedure
Clinically Indicated Target Vessel Revascularization (TVR)
Time frame: At 1 and 12 months post-procedure
Procedural Success Rate
Time frame: During the index percutaneous coronary intervention (PCI) procedure and until hospital discharge (up to 24 hours post-procedure).
Final Residual Stent Underexpansion
Time frame: At the end of the index percutaneous coronary intervention (PCI) procedure (immediate post-stenting optimization).
Final Stent Diameter Stenosis
Time frame: At the end of the index percutaneous coronary intervention (PCI) procedure.
Rate of Procedural Complications
Time frame: During the index percutaneous coronary intervention (PCI) procedure (immediate intra-procedural period).
Procedural Cost-Effectiveness
Time frame: During the index percutaneous coronary intervention (PCI) procedure.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Background: PubMed 29897428Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Eur Heart J. 2018 Jun 14;39(23):2192-2207. doi: 10.1093/eurheartj/ehy223.
Background: PubMed 27400292Jujo K, Saito K, Ishida I, Kim A, Suzuki Y, Furuki Y, Ouchi T, Ishii Y, Sekiguchi H, Yamaguchi J, Ogawa H, Hagiwara N. Intimal disruption affects drug-eluting cobalt-chromium stent expansion: A randomized trial comparing scoring and conventional balloon predilation. Int J Cardiol. 2016 Oct 15;221:23-31. doi: 10.1016/j.ijcard.2016.07.002. Epub 2016 Jul 4.
Background: PubMed 39132214Riley RF, Patel MP, Abbott JD, Bangalore S, Brilakis ES, Croce KJ, Doshi D, Kaul P, Kearney KE, Kerrigan JL, McEntegart M, Maehara A, Rymer JA, Sutton NR, Shah B. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions. J Soc Cardiovasc Angiogr Interv. 2024 Jan 31;3(2):101259. doi: 10.1016/j.jscai.2023.101259. eCollection 2024 Feb.
Background: PubMed 37208199Barbato E, Gallinoro E, Abdel-Wahab M, Andreini D, Carrie D, Di Mario C, Dudek D, Escaned J, Fajadet J, Guagliumi G, Hill J, McEntegart M, Mashayekhi K, Mezilis N, Onuma Y, Reczuch K, Shlofmitz R, Stefanini G, Tarantini G, Toth GG, Vaquerizo B, Wijns W, Ribichini FL. Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group. Eur Heart J. 2023 Nov 1;44(41):4340-4356. doi: 10.1093/eurheartj/ehad342.
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Individual participant dataSharing planned: Yes. The individual participant data (IPD) that underlie the results reported in this publication, including the final minimal stent area (MSA) measurements, procedural success data, and relevant clinical adverse event records, will be shared. Supporting documents, including the study protocol, statistical analysis plan, and informed consent forms, will be provided to support the interpretation of the IPD. All data shared will be de-identified to maintain participant confidentiality in accordance with GDPR requirements.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Stéphane Carlier, MD, PhD contact

+3265373381

stephane.carlier@umons.ac.be

Stéphane Carlier, MD, PhD principal investigator

University of Mons

Antonio Serra principal investigator

14 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Belgium, Spain, Luxembourg, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stéphane Carlier, MD, PhD (+3265373381, stephane.carlier@umons.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Final Minimal Stent Area (MSA) (time frame: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07650578, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.