Prospektivní, multicentrická, randomizovaná kontrolovaná studie zkoumající hodnotu koronární CT angiografie v pochopení a léčbě koronárního kalcia (The Optimal Trial)
Prospektivní, multicentrická, randomizovaná kontrolovaná studie zaměřená na zkoumání hodnoty koronární CT angiografie v pochopení a léčbě koronárního kalcifikace
The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
The OPTIMAL Trial is a prospective, multicenter, randomized controlled study evaluating whether a coronary CT angiography (CCTA)-guided calcium modification strategy can improve the treatment of patients with hemodynamically significant, calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).
Seven hundred patients with flow-limiting stenosis (FFRCT ≤0.80) and moderate-to-severe calcification on CCTA will be randomized 1:1 to either CCTA-guided or intravascular ultrasound (IVUS)-guided calcium modification. The study includes two co-primary endpoints: (1) superiority in final minimal stent area assessed by IVUS, and (2) non-inferiority in 12-month target vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization).
CCTA-guided strategy uses advanced calcium characterization to inform pre-procedural planning and selection of plaque modification techniques. IVUS-guided strategy follows contemporary intravascular imaging-based criteria for plaque preparation and PCI optimization.
The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining clinical safety comparable to IVUS-guided PCI.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: CAROLINA FOCELLA
- Telefonní číslo: 001 917 753 6695
- E-mail: cfocella@crf.org
Studijní záloha kontaktů
- Jméno: CARLOS COLLET, MD,PhD
- Telefonní číslo: 001 917 753 6695
- E-mail: carloscollet@gmail.com
Studijní místa
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Aalst, Belgie, 9300
- Nábor
- Azorg Hospital, Aalst
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Leicester, Spojené království
- Nábor
- University Hospitals of Leicester NHS Trust
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London, Spojené království
- Nábor
- St Bartholomew's Hospital (Barts Health NHS Trust)
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London, Spojené království
- Nábor
- St George's University Hospitals NHS Foundations Trust
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Kontakt:
- James Spratt, MD, PhD
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London, Spojené království
- Nábor
- Guys & St Thomas Nhs Foundation Trust
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Newcastle, Spojené království
- Zatím nenabíráme
- Newcastle Hospitals NHS Foundations Trust
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Oxford, Spojené království
- Zatím nenabíráme
- John Radcliffe Hospital, Oxford
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Zatím nenabíráme
- Bringham and Women's Hospital
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55407
- Nábor
- Minneapolis Heart Institute
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New Jersey
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Jersey City, New Jersey, Spojené státy, 08837
- Zatím nenabíráme
- HACKENSACK MERIDIAN HEALTH, Inc
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New York
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New York, New York, Spojené státy, 14853
- Zatím nenabíráme
- Weill Medical College of Cornell University
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New York, New York, Spojené státy, 10032
- Nábor
- NewYork-Presbyterian/Weill Cornell Medical Center
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Barcelona, Španělsko, 08035
- Nábor
- Hospital Universitari Vall Hebron
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León, Španělsko
- Nábor
- Hospital Universitario de Leon
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Madrid, Španělsko, 28046
- Nábor
- Hospital Universitario La Paz
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- The subject must be at least 18 years of age and younger than 85 years old
- Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
- All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
- Subject must provide written informed consent before any study-related procedure
Exclusion Criteria:
- STEMI as the clinical presentation.
- Uncontrolled or recurrent ventricular tachycardia.
- Hemodynamic instability.
- Hemodialysis or peritoneal dialysis.
- Left main coronary artery stenosis > 50%
- Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
- Previous PCI in the target vessel or CABG.
- BMI ≥ 40 kg/m2
- Insufficient CT quality assessed by the Core lab.
- Comorbidity with life expectancy ≤ 2 years.
- Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
- The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
- The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
- The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
- Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
- The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
- The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause.
- Subject is currently participating in another investigational drug or device clinical study.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Unable to provide written informed consent (IC).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: CT-guide calcium modification strategy
Pre-procedural CT will be used to determine lesion characteristics. |
CT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent |
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Aktivní komparátor: IVUS-guide calcium modification strategy
Pre-procedural IVUS will be used to determine lesion characteristics. |
IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
Časové okno: Perioperative/Periprocedural
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Final post-PCI minimal stent area per target lesion, measured by independent core laboratory using intravascular ultrasound (IVUS). Assesses whether CT-guided calcium modification results in superior stent expansion compared with IVUS-guided PCI. |
Perioperative/Periprocedural
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Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority)
Časové okno: 12 months
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Composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR). TV-MI and ID-TVR are defined according to ARC-2 and the Fourth Universal Definition of MI. |
12 months
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Procedural efficiency: Procedure time
Časové okno: During PCI
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Time from first angiogram to final angiogram |
During PCI
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Procedural efficiency:Radiation dose-area product
Časové okno: During PCI
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Dose-area product (DAP) recorded during PCI. |
During PCI
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Procedural efficiency: Contrast volume
Časové okno: During PCI
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Total contrast volume (mL) used during PCI.IVUS-Derived Mechanistic Endpoints (Core Lab) |
During PCI
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Procedural Efficiency: Stent Area on Immediate Post-Stent IVUS
Časové okno: Perioperative/Periprocedural
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MSA prior to any final IVUS-guided optimization. |
Perioperative/Periprocedural
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Procedural Efficiency: Final Stent Area at Original Minimal Lumen Area (MLA)
Časové okno: Perioperative/Periprocedural
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Stent area at the co-registered site of the baseline MLA. |
Perioperative/Periprocedural
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Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Arc
Časové okno: Perioperative/Periprocedural
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Stent area measured at the co-registered IVUS site with maximal calcium arc |
Perioperative/Periprocedural
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Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Density
Časové okno: Perioperative/Periprocedural
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Stent area measured at the co-registered CT-identified region of greatest Hounsfield Unit (HU) calcium density. |
Perioperative/Periprocedural
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Procedural Efficiency: Relative Stent Expansion
Časové okno: Perioperative/Periprocedural
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Percentage expansion calculated as: MSA ÷ mean distal reference lumen area × 100. |
Perioperative/Periprocedural
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Procedural Efficiency: Number of Calcium Fractures
Časové okno: Post-modification, pre-stent
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Fractures identified on intermediary IVUS after calcium modification. |
Post-modification, pre-stent
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Procedural Efficiency: Change in Plaque Attenuation
Časové okno: Post-modification, pre-stent
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Change in IVUS plaque characteristics following calcium modification.Angiographic Endpoints |
Post-modification, pre-stent
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Procedural Efficiency: Final Minimal Lumen Diameter
Časové okno: Perioperative/Periprocedural
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Minimum lumen diameter by quantitative coronary angiography (QCA) |
Perioperative/Periprocedural
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Procedural Efficiency: Final Percent Diameter Stenosis
Časové okno: Perioperative/Periprocedural
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Percent stenosis of treated lesion after PCI, by QCA |
Perioperative/Periprocedural
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Procedural Efficiency: Final TIMI Flow Grade
Časové okno: Perioperative/Periprocedural
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Target vessel flow graded 0-3 based on TIMI criteria. Thrombolysis In Myocardial Infarction (TIMI) Flow Grade is a 0-3 angiographic scale used during coronary angiography to describe how well blood is flowing through a coronary artery.TIMI 0 No perfusion, TIMI 1 Penetration without perfusion, TIMI 2 Partial perfusion TIMI 3 Complete perfusion (normal flow) |
Perioperative/Periprocedural
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Procedural Efficiency: Angiographic Complications
Časové okno: Day of procedure
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According to Coronary dissection (NHLBI classification) |
Day of procedure
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Procedural Efficiency: Angiographic Complications
Časové okno: Day of procedure
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According to Coronary perforation (Ellis classification) |
Day of procedure
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Procedural Efficiency: Angiographic Complications
Časové okno: Day of procedure
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Slow-flow / no-reflow |
Day of procedure
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Procedural Efficiency: Angiographic Complications
Časové okno: Day of procedure
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Side branch closure (TIMI 0-1) |
Day of procedure
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Clinical & Safety Outcomes: Procedural Success
Časové okno: Perioperative/Periprocedural
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Final stenosis <30%, TIMI 3 flow, no angiographic complications, and no in-hospital major adverse cardiac events (MACE). |
Perioperative/Periprocedural
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Clinical & Safety Outcomes: Periprocedural Myocardial Infarction (Type 4a MI)
Časové okno: Day 0-1
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Defined by ARC-2 and 4th Universal Definition of MI (troponin criteria + evidence of ischemia). |
Day 0-1
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Clinical & Safety Outcomes: Stent Thrombosis
Časové okno: Up to 12 months
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Definite or probable stent thrombosis according to ARC-2 definitions. |
Up to 12 months
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Patient-Reported Outcomes: Residual Angina (SAQ-7 Angina Frequency)
Časové okno: 12 months
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Residual angina defined as SAQ-7 Angina Frequency score <100. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently |
12 months
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Patient-Reported Outcomes: Change in Angina (SAQ-7)
Časové okno: Baseline to 12 months
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Change in angina frequency domain score; positive values indicate improvement. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently |
Baseline to 12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Collet C, Sonck J, Vandeloo B, Mizukami T, Roosens B, Lochy S, Argacha JF, Schoors D, Colaiori I, Di Gioia G, Kodeboina M, Suzuki H, Van 't Veer M, Bartunek J, Barbato E, Cosyns B, De Bruyne B. Measurement of Hyperemic Pullback Pressure Gradients to Characterize Patterns of Coronary Atherosclerosis. J Am Coll Cardiol. 2019 Oct 8;74(14):1772-1784. doi: 10.1016/j.jacc.2019.07.072.
- Sonck J, Nagumo S, Norgaard BL, Otake H, Ko B, Zhang J, Mizukami T, Maeng M, Andreini D, Takahashi Y, Jensen JM, Ihdayhid A, Heggermont W, Barbato E, Mileva N, Munhoz D, Bartunek J, Updegrove A, Collinsworth A, Penicka M, Van Hoe L, Leipsic J, Koo BK, De Bruyne B, Collet C. Clinical Validation of a Virtual Planner for Coronary Interventions Based on Coronary CT Angiography. JACC Cardiovasc Imaging. 2022 Jul;15(7):1242-1255. doi: 10.1016/j.jcmg.2022.02.003. Epub 2022 Apr 13.
- Tajima A, Bouisset F, Ohashi H, Sakai K, Mizukami T, Rizzini ML, Gallo D, Chiastra C, Morbiducci U, Ali ZA, Spratt JC, Ando H, Amano T, Kitslaar P, Wilgenhof A, Sonck J, De Bruyne B, Collet C. Advanced CT Imaging for the Assessment of Calcific Coronary Artery Disease and PCI Planning. J Soc Cardiovasc Angiogr Interv. 2024 Mar 26;3(3Part B):101299. doi: 10.1016/j.jscai.2024.101299. eCollection 2024 Mar.
- Monizzi G, Sonck J, Nagumo S, Buytaert D, Van Hoe L, Grancini L, Bartorelli AL, Vanhoenacker P, Simons P, Bladt O, Wyffels E, De Bruyne B, Andreini D, Collet C. Quantification of calcium burden by coronary CT angiography compared to optical coherence tomography. Int J Cardiovasc Imaging. 2020 Dec;36(12):2393-2402. doi: 10.1007/s10554-020-01839-z. Epub 2020 Nov 17.
- Collet C, Collison D, Mizukami T, McCartney P, Sonck J, Ford T, Munhoz D, Berry C, De Bruyne B, Oldroyd K. Differential Improvement in Angina and Health-Related Quality of Life After PCI in Focal and Diffuse Coronary Artery Disease. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2506-2518. doi: 10.1016/j.jcin.2022.09.048. Epub 2022 Nov 30.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- EPIC46-THE OPTIMAL TRIAL
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