Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon (MILOU)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Stéphane Carlier, MD, PhD
- 전화번호: +3265373381
- 이메일: stephane.carlier@umons.ac.be
연구 장소
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Luxembourg, 룩셈부르크, 1210
- INCCI Haerz Zenter
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연락하다:
- Bruno Pereira, MD
- 전화번호: + 352 691 86 31 86
- 이메일: dr.pereira@pt.lu
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수석 연구원:
- Bruno Pereira, MD
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Bonheiden, 벨기에, 2820
- Imelda
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Brussels, 벨기에, 1070
- Hôpital Erasme - Cliniques universitaires de Bruxelles
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연락하다:
- Gabriela Flores Vivian, MD
- 전화번호: +3225554290
- 이메일: g.floresvivian@hubruxelles.be
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수석 연구원:
- Gabriela Flores Vivian, MD
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Libramont, 벨기에, 6800
- Hôpital Vivalia
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연락하다:
- Chadi Ghafari, MD, PhD
- 전화번호: +32483128996
- 이메일: chadi_ghafari@yahoo.com
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수석 연구원:
- Chadi Ghafari, MD, PhD
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Liège, 벨기에, 4000
- CHR de la Citadelle
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연락하다:
- Georges Saad, MD
- 전화번호: +3243217155
- 이메일: georges.saad@citadelle.be
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연락하다:
- Sophie Jacquet
- 전화번호: +3243217820
- 이메일: rc-cardio@citadelle.be
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수석 연구원:
- Georges Saad, MD
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Lodelinsart, 벨기에, 6042
- Humani CHU Charleroi - Chimay
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연락하다:
- Cellule de recherche clinique
- 전화번호: +32071920545
- 이메일: cellule.recherche.clinique@humani.be
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수석 연구원:
- Mohamed Ben Yedder, MD
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Hainaut
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Mons, Hainaut, 벨기에, 7000
- CHU - HELORA site Kennedy
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연락하다:
- Stéphane Carlier, MD, PhD
- 전화번호: +3265373381
- 이메일: stephane.carlier@umons.ac.be
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수석 연구원:
- Stéphane Carlier, MD, Phd
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Barcelona, 스페인, 08025
- Hospital de Sant Pau
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연락하다:
- Estefanía Fernández-Peregrina, MD
- 전화번호: +34628839525
- 이메일: efernandezpe@santpau.cat
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연락하다:
- Elena Jiménez Xarrié
- 전화번호: +34628839525
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수석 연구원:
- Estefanía Fernández-Peregrina, MD
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Barcelona, 스페인, 08901-08908
- Hospital Universitari de Bellvitge
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연락하다:
- Andrea Ruberti
- 전화번호: +34 932 60 75 00
- 이메일: andreaalbertoruberti@bellvitgehospital.cat
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수석 연구원:
- Andrea Ruberti, MD
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Cadiz, 스페인, 11009
- Hospital Puerta del Mar
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연락하다:
- Alejandro Gutiérrez-Barrios, MD
- 전화번호: +34 620688877
- 이메일: aleklos@hotmail.com
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수석 연구원:
- Alejandro Gutiérrez-Barrios, MD
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Cáceres, 스페인, 10003
- Hospital San Pedro De Alcantara
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연락하다:
- Juan Carlos Rama
- 전화번호: +34615611413
- 이메일: ramamerchan@hotmail.com
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수석 연구원:
- Juan Carlos Rama, MD
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Valencia, 스페인, 46026
- Hospital La Fe
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연락하다:
- Jorge Sanz Sanchez
- 전화번호: +34 660360598
- 이메일: sjorge4@gmx.com
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연락하다:
- Ines Roche Fortea
- 이메일: ines_roche@islafe.es
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수석 연구원:
- Jorge Sanz Sanchez, MD
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Valladolid, 스페인, 47003
- Hospital Clínico Universitario de Valladolid
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수석 연구원:
- Ignacio J Amat Santos, MD
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연락하다:
- Ignacio J Amat Santos, MD
- 전화번호: 86571 +34983420000
- 이메일: ijamat@gmail.com
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연락하다:
- Carlos Baladrón Zorita
- 전화번호: 86571 +34983 42 00 00
- 이메일: cbaladron@icicor.es
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Vila Nova de Gaia, 포르투갈, 4430-999
- Centro Hospitalar de Vila Nova de Gaia/Espinho
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연락하다:
- Alberto Rodrigues
- 전화번호: +351919589753
- 이메일: rodrigues.jal@gmail.com
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수석 연구원:
- Alberto Rodrigues, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Standard NC group
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.
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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.
다른 이름들:
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실험적: Naviscore group
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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Final Minimal Stent Area (MSA)
기간: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.
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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.
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Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Minimal Stent Area (MSA) Across the Entire Stented Segment
기간: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
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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
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Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
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Stent Eccentricity at the Site of the Minimal Stent Area
기간: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
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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
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Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
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Stent Eccentricity at the Initial Heaviest Calcium Burden Site
기간: Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
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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
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Immediately post-stenting optimization during the index percutaneous coronary intervention (PCI) procedure
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Device Success Rate
기간: During the index percutaneous coronary intervention (PCI) procedure
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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
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During the index percutaneous coronary intervention (PCI) procedure
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Major Adverse Cardiac Events (MACE) Rate
기간: At 1 and 12 months post-procedure
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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
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At 1 and 12 months post-procedure
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Target Lesion Failure (TLF)
기간: At 1 and 12 months post-procedure
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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
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At 1 and 12 months post-procedure
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Target Vessel Failure (TVF)
기간: At 1 and 12 months post-procedure
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Defined as a composite of cardiac death, target-vessel myocardial infarction, or clinically indicated Target Vessel Revascularization (TVR).
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At 1 and 12 months post-procedure
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Clinically Indicated Target Lesion Revascularization (TLR)
기간: At 1 and 12 months post-procedure
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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.
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At 1 and 12 months post-procedure
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Clinically Indicated Target Vessel Revascularization (TVR)
기간: At 1 and 12 months post-procedure
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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.
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At 1 and 12 months post-procedure
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Procedural Success Rate
기간: During the index percutaneous coronary intervention (PCI) procedure and until hospital discharge (up to 24 hours post-procedure).
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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).
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During the index percutaneous coronary intervention (PCI) procedure and until hospital discharge (up to 24 hours post-procedure).
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Final Residual Stent Underexpansion
기간: At the end of the index percutaneous coronary intervention (PCI) procedure (immediate post-stenting optimization).
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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.
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At the end of the index percutaneous coronary intervention (PCI) procedure (immediate post-stenting optimization).
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Final Stent Diameter Stenosis
기간: At the end of the index percutaneous coronary intervention (PCI) procedure.
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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.
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At the end of the index percutaneous coronary intervention (PCI) procedure.
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Rate of Procedural Complications
기간: During the index percutaneous coronary intervention (PCI) procedure (immediate intra-procedural period).
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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.
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During the index percutaneous coronary intervention (PCI) procedure (immediate intra-procedural period).
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Procedural Cost-Effectiveness
기간: During the index percutaneous coronary intervention (PCI) procedure.
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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.
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During the index percutaneous coronary intervention (PCI) procedure.
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Stéphane Carlier, MD, PhD, University of Mons
- 수석 연구원: Antonio Serra
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 009 (Nahrain Medical Research Collective (NMRC))
- Unrestricted grant (기타 보조금/기금 번호: iVascular)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .