Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon (MILOU)
10. června 2026 aktualizováno: Stephane Carlier, University of Mons
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.
Přehled studie
Postavení
Zatím nenabíráme
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
200
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Stéphane Carlier, MD, PhD
- Telefonní číslo: +3265373381
- E-mail: stephane.carlier@umons.ac.be
Studijní místa
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Bonheiden, Belgie, 2820
- Imelda
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Brussels, Belgie, 1070
- Hôpital Erasme - Cliniques universitaires de Bruxelles
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Kontakt:
- Gabriela Flores Vivian, MD
- Telefonní číslo: +3225554290
- E-mail: g.floresvivian@hubruxelles.be
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Vrchní vyšetřovatel:
- Gabriela Flores Vivian, MD
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Libramont, Belgie, 6800
- Hôpital Vivalia
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Kontakt:
- Chadi Ghafari, MD, PhD
- Telefonní číslo: +32483128996
- E-mail: chadi_ghafari@yahoo.com
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Vrchní vyšetřovatel:
- Chadi Ghafari, MD, PhD
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Liège, Belgie, 4000
- CHR de la Citadelle
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Kontakt:
- Georges Saad, MD
- Telefonní číslo: +3243217155
- E-mail: georges.saad@citadelle.be
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Kontakt:
- Sophie Jacquet
- Telefonní číslo: +3243217820
- E-mail: rc-cardio@citadelle.be
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Vrchní vyšetřovatel:
- Georges Saad, MD
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Lodelinsart, Belgie, 6042
- Humani CHU Charleroi - Chimay
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Kontakt:
- Cellule de recherche clinique
- Telefonní číslo: +32071920545
- E-mail: cellule.recherche.clinique@humani.be
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Vrchní vyšetřovatel:
- Mohamed Ben Yedder, MD
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Hainaut
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Mons, Hainaut, Belgie, 7000
- CHU - HELORA site Kennedy
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Kontakt:
- Stéphane Carlier, MD, PhD
- Telefonní číslo: +3265373381
- E-mail: stephane.carlier@umons.ac.be
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Vrchní vyšetřovatel:
- Stéphane Carlier, MD, Phd
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Luxembourg, Lucembursko, 1210
- INCCI Haerz Zenter
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Kontakt:
- Bruno Pereira, MD
- Telefonní číslo: + 352 691 86 31 86
- E-mail: dr.pereira@pt.lu
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Vrchní vyšetřovatel:
- Bruno Pereira, MD
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Vila Nova de Gaia, Portugalsko, 4430-999
- Centro Hospitalar de Vila Nova de Gaia/Espinho
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Kontakt:
- Alberto Rodrigues
- Telefonní číslo: +351919589753
- E-mail: rodrigues.jal@gmail.com
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Vrchní vyšetřovatel:
- Alberto Rodrigues, MD
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Barcelona, Španělsko, 08025
- Hospital de Sant Pau
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Kontakt:
- Estefanía Fernández-Peregrina, MD
- Telefonní číslo: +34628839525
- E-mail: efernandezpe@santpau.cat
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Kontakt:
- Elena Jiménez Xarrié
- Telefonní číslo: +34628839525
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Vrchní vyšetřovatel:
- Estefanía Fernández-Peregrina, MD
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Barcelona, Španělsko, 08901-08908
- Hospital Universitari de Bellvitge
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Kontakt:
- Andrea Ruberti
- Telefonní číslo: +34 932 60 75 00
- E-mail: andreaalbertoruberti@bellvitgehospital.cat
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Vrchní vyšetřovatel:
- Andrea Ruberti, MD
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Cadiz, Španělsko, 11009
- Hospital Puerta del Mar
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Kontakt:
- Alejandro Gutiérrez-Barrios, MD
- Telefonní číslo: +34 620688877
- E-mail: aleklos@hotmail.com
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Vrchní vyšetřovatel:
- Alejandro Gutiérrez-Barrios, MD
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Cáceres, Španělsko, 10003
- Hospital San Pedro De Alcantara
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Kontakt:
- Juan Carlos Rama
- Telefonní číslo: +34615611413
- E-mail: ramamerchan@hotmail.com
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Vrchní vyšetřovatel:
- Juan Carlos Rama, MD
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Valencia, Španělsko, 46026
- Hospital La Fe
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Kontakt:
- Jorge Sanz Sanchez
- Telefonní číslo: +34 660360598
- E-mail: sjorge4@gmx.com
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Kontakt:
- Ines Roche Fortea
- E-mail: ines_roche@islafe.es
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Vrchní vyšetřovatel:
- Jorge Sanz Sanchez, MD
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Valladolid, Španělsko, 47003
- Hospital Clínico Universitario de Valladolid
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Vrchní vyšetřovatel:
- Ignacio J Amat Santos, MD
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Kontakt:
- Ignacio J Amat Santos, MD
- Telefonní číslo: 86571 +34983420000
- E-mail: ijamat@gmail.com
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Kontakt:
- Carlos Baladrón Zorita
- Telefonní číslo: 86571 +34983 42 00 00
- E-mail: cbaladron@icicor.es
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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.
Ostatní jména:
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Final Minimal Stent Area (MSA)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Minimal Stent Area (MSA) Across the Entire Stented Segment
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Stéphane Carlier, MD, PhD, University of Mons
- Vrchní vyšetřovatel: Antonio Serra
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
1. června 2027
Dokončení studie (Odhadovaný)
1. června 2028
Termíny zápisu do studia
První předloženo
10. června 2026
První předloženo, které splnilo kritéria kontroly kvality
10. června 2026
První zveřejněno (Aktuální)
16. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
16. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 009 (Nahrain Medical Research Collective (NMRC))
- Unrestricted grant (Jiné číslo grantu/financování: iVascular)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
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.
Časový rámec sdílení IPD
Beginning 6 months after the publication of the study results and ending 5 years following the publication date.
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .