Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Scoring Balloon PTCA Catheter
  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
• Устройство Non-Compliant (NC) Angioplasty 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.

Первичные конечные точки

• Final Minimal Stent Area (MSA) [Срок оценки: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 6 центров

• CHU - HELORA site Kennedy — Mons
• Imelda — Bonheiden
• Hôpital Erasme - Cliniques universitaires de Bruxelles — Brussels
• Hôpital Vivalia — Libramont
• CHR de la Citadelle — Liège
• Humani CHU Charleroi - Chimay — Lodelinsart

Испания · 6 центров

• Hospital de Sant Pau — Barcelona
• Hospital Universitari de Bellvitge — Barcelona
• Hospital Puerta Del Mar — Cadiz
• Hospital San Pedro de Alcantara — Cáceres
• Hospital La Fe — Valencia
• Hospital Clínico Universitario de Valladolid — Valladolid

Luxembourg · 1 центр

• INCCI Haerz Zenter — Luxembourg

Португалия · 1 центр

• Centro Hospitalar de Vila Nova de Gaia/Espinho — Vila Nova de Gaia

Публикации

• 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):2192-22 PMID 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. PMID 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. PMID 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 EURO4 PMID 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 O PMID 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. PMID 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. PMID 40438639

Идентификаторы

NCT: NCT07650578 · 009 · Unrestricted grant

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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