Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon

NCT07650578 | Not Yet Recruiting

• 2 other identifiers: 009Unrestricted grant
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 14

Brief Summary

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.

Conditions

Coronary Arterial Disease (CAD); Calcific Coronary Arteriosclerosis

Keywords

Percutaneous Coronary Intervention; Lesion Preparation; Scoring Balloon; Intravascular Ultrasound; Stent Expansion; Coronary Artery Calcification

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.

Secondary Outcomes (14)

• Minimal Stent Area (MSA) Across the Entire Stented Segment

  Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure

• Stent Eccentricity at the Site of the Minimal Stent Area

  Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure

• Stent Eccentricity at the Initial Heaviest Calcium Burden Site

  Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure

• Device Success Rate

  During the index percutaneous coronary intervention (PCI) procedure

• Major Adverse Cardiac Events (MACE) Rate

  At 1 and 12 months post-procedure

Study Arms (2)

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.

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.

Device: Scoring Balloon PTCA Catheter

Interventions

Scoring Balloon PTCA Catheter DEVICE

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.

Also known as: Naviscore Scoring Balloon

Naviscore group

Non-Compliant (NC) Angioplasty Balloon DEVICE

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.

Also known as: Conventional PTCA Balloon

Standard NC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Mons: lead
• iVascular S.L.U.: collaborator

Study Sites (14)

CHU - HELORA site Kennedy

Mons, Hainaut, 7000, Belgium

Location

Imelda

Bonheiden, 2820, Belgium

Location

Hôpital Erasme - Cliniques universitaires de Bruxelles

Brussels, 1070, Belgium

Location

Hôpital Vivalia

Libramont, 6800, Belgium

Location

CHR de la Citadelle

Liège, 4000, Belgium

Location

Humani CHU Charleroi - Chimay

Lodelinsart, 6042, Belgium

Location

INCCI Haerz Zenter

Luxembourg, 1210, Luxembourg

Location

Centro Hospitalar de Vila Nova de Gaia/Espinho

Vila Nova de Gaia, 4430-999, Portugal

Location

Hospital de Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08901-08908, Spain

Location

Hospital Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, 10003, Spain

Location

Hospital La Fe

Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Related Publications (7)

• 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.

  PMID: 29897428 BACKGROUND

• 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.

  PMID: 27400292 BACKGROUND

• 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.

  PMID: 39132214 BACKGROUND

• 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.

  PMID: 37208199 BACKGROUND

• 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.

  PMID: 34665658 BACKGROUND

• 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.

  PMID: 36841945 BACKGROUND

• 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.

  PMID: 40438639 BACKGROUND

MeSH Terms

Interventions

Angioplasty, Balloon

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Stéphane Carlier, MD, PhD

  University of Mons

  PRINCIPAL INVESTIGATOR

• Antonio Serra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphane Carlier, MD, PhD

CONTACT

+3265373381; stephane.carlier@umons.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after the publication of the study results and ending 5 years following the publication date.
• Access Criteria: Access is granted to researchers who provide a methodologically sound proposal for secondary analysis. Proposals must be submitted to the Principal Investigators at the University of Mons (UMONS), Belgium. The study's Steering Committee will review each request. Upon approval, data will be shared under a signed data sharing agreement ensuring strict adherence to participant privacy and institutional ethical guidelines.

Locations

BE (6); ES (6); PT (1); LU (1)