Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies (FLOW-DCB)
Comparison of Fractional FLOW Reserve Outcomes With Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Percutaneous Coronary Intervention Strategies (FLOW-DCB): A Multicenter, Prospective, Randomized Controlled, Non-inferiority Trial
The goal of this clinical trial is to find out whether a treatment strategy based on a drug-coated balloon (DCB) achieves coronary artery function at 6 months that is not worse than a strategy using only drug-eluting stents (DES) by more than a prespecified amount. The study will enroll adults undergoing percutaneous coronary intervention (PCI) for a new coronary artery narrowing (de novo lesion).
The main questions are:
- Is fractional flow reserve (FFR) at 6 months noninferior after DCB-based PCI compared with DES-only PCI? FFR is a pressure-based measure used to assess blood flow through a coronary artery.
- Does the DCB-based strategy reduce the number and total length of stents implanted?
- What cardiovascular events or medical problems, such as cardiovascular death, myocardial infarction, repeat coronary procedures, or bleeding, occur during follow-up?
Investigators will randomly assign 100 participants to one of two treatment strategies. In the DCB-based group, the lesion will first be prepared with a balloon. A DCB will be used if lesion preparation produces a suitable result; a DES may be implanted if needed to achieve a safe and adequate result. In the DES-only group, the lesion will be treated with a DES.
Participants will:
- Receive treatment according to their assigned strategy.
- Undergo follow-up coronary angiography and FFR measurement at approximately 6 months. For clinical reasons, this examination may take place up to 9 months after the procedure.
- Be followed for cardiovascular events through 12 months after randomization.
Обзор исследования
Статус
Статус
Условия
Условия
Вмешательство/лечение
Вмешательство/лечение
Подробное описание
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Background and objective Drug-coated balloons (DCBs) deliver an antiproliferative drug to the vessel wall during balloon inflation without leaving a permanent metallic implant. Drug-eluting stents (DESs) provide a permanent metallic scaffold that releases an antiproliferative drug. A DCB-based strategy prioritizes DCB treatment after adequate lesion preparation while allowing DES implantation when the procedural result is unsuitable for DCB treatment. Whether this strategy preserves coronary physiological function at follow-up compared with routine DES implantation remains uncertain. The FLOW-DCB trial will test whether DCB-based percutaneous coronary intervention (PCI) is noninferior to DES-only PCI with respect to fractional flow reserve (FFR) measured distal to the target or culprit lesion at approximately 6 months.
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Study design and population FLOW-DCB is an investigator-initiated, multicenter, prospective, randomized, parallel-group noninferiority trial conducted at four hospitals in the Republic of Korea. A total of 100 adults with angina or myocardial infarction requiring PCI for a de novo coronary lesion will be randomized 1:1 after diagnostic coronary angiography and before lesion preparation. The target or culprit lesion must be suitable for either strategy and have a reference vessel diameter of at least 2.25 mm. Randomization is web-based and stratified by center and clinical diagnosis at PCI (acute vs. chronic coronary syndrome).
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Treatment strategies In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover.
In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice. Intravascular ultrasound or optical coherence tomography may be used in either group at the operator's discretion. Antiplatelet and other medical treatments will be individualized according to current practice, the actual procedure, and the participant's bleeding and ischemic risks.
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Assessments and outcomes Follow-up coronary angiography and FFR measurement are planned at 6 months after randomization, with a ±30-day window; follow-up testing may be performed up to 9 months after the procedure for clinical reasons. A pressure-sensing wire will be placed distal to the treated lesion, and FFR will be recorded during maximal hyperemia. Proximal FFR and the pressure difference across the lesion (trans-lesion ΔFFR) will be recorded when feasible. Pressure drift will be checked at the end of measurement. FFR before or immediately after PCI may be obtained but is not mandatory.
The primary endpoint is mean FFR distal to the target or culprit lesion at follow-up. Secondary physiological and angiographic outcomes include trans-lesion ΔFFR, quantitative coronary angiographic measures, and the total number and length of implanted stents. Exploratory analyses will assess the effect of follow-up timing and changes in FFR when a baseline measurement is available. Clinical events, including death, myocardial infarction, repeat coronary revascularization, lesion or stent thrombosis, and clinically relevant bleeding, will be assessed through 12 months after randomization. Clinical events and safety data will be reviewed by an independent committee.
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Statistical considerations The noninferiority margin for the difference in mean distal FFR (DCB-based PCI minus DES-only PCI) is -0.05. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval for this difference exceeds -0.05 (one-sided alpha 0.025). The protocol targets at least 25 evaluable FFR measurements per group and randomizes 50 per group to account for unavailable follow-up measurements. The primary analysis will use available FFR measurements within the protocol-defined follow-up window, according to the randomized treatment group; per-protocol and exploratory as-treated analyses are planned. The trial is designed to assess physiological noninferiority and is not powered to establish differences in clinical events.
Тип исследования
Тип исследования
Регистрация (Оцененный)
Регистрация
Фаза
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
Контакты исследования
- Имя: Dong Oh Kang, MD, PhD
- Номер телефона: 82-2-2626-3184
- Электронная почта: gelly9@naver.com
Учебное резервное копирование контактов
- Имя: Soohyung Park, MD, PhD
- Номер телефона: +82-2-2626-1108
- Электронная почта: shp503@naver.com
Места учебы
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Seoul, Южная Корея, 02841
- Korea University Anam Hospital
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Контакт:
- Jung-Joon Cha, MD, PhD
- Номер телефона: +82-920-5445
- Электронная почта: jungjoon@kumc.or.kr
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Seoul, Южная Корея, 08308
- Korea University Guro Hospital
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Контакт:
- Dong Oh Kang, MD, PhD
- Номер телефона: +82-2-2626-3184
- Электронная почта: gelly9@naver.com
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Контакт:
- Soohyung Park, MD, PhD
- Электронная почта: shp503@naver.com
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Seoul, Южная Корея, 04763
- Hanyang University Seoul Hospital
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Контакт:
- Woohyeun Kim, MD, PhD
- Номер телефона: +82-2-2290-8114
- Электронная почта: coincidence1@naver.com
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Seoul, Южная Корея, 01450
- Hanil General Hospital
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Контакт:
- Ji Bak Kim, MD, PhD
- Номер телефона: +82-2-901-3114
- Электронная почта: dr3120@gmail.com
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Критерии участия
Критерии приемлемости
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adults aged 19 years or older.
- Patients requiring coronary revascularization for angina or myocardial infarction.
- A target or culprit lesion suitable for both DCB and DES treatment.
- Reference vessel diameter of the target or culprit lesion ≥2.25 mm.
- Voluntary written informed consent after an explanation of the study objectives and procedures.
- For foreign nationals, ability to communicate in Korean.
Exclusion Criteria:
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Active bleeding, a clinically significant bleeding tendency, or a coagulation disorder.
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Hypersensitivity or a contraindication to aspirin, P2Y12 inhibitors, or components of a DES or DCB (drug, polymer, or metal).
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Refractory cardiogenic shock.
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Angiographic exclusion:
- Target lesion in ISR (in-stent restenosis).
- Target lesion in a bypass graft.
- Chronic total occlusion
- Left main coronary artery disease.
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History of stent thrombosis.
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Expected survival of less than 1 year because of comorbid illness.
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Left ventricular ejection fraction ≤20%.
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Pregnancy or breastfeeding.
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In the investigator's judgment, unsuitable for study participation for clinical or anatomical reasons.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Количество рук
Оружие и интервенции
Группа участников / АрмияГруппа участников / Армия |
Вмешательство/лечениеВмешательство/лечение |
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Экспериментальный: DCB-based PCI group
In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover. |
In the DCB-based PCI group, lesion preparation may include conventional, non-compliant, cutting, or scoring balloons and, when needed, other calcium-modification techniques. An adequately prepared lesion has expansion with a balloon-to-vessel diameter ratio of at least 0.90, residual diameter stenosis of 30% or less, TIMI grade 3 flow, and no flow-limiting dissection or risk of vessel closure. When these conditions are met, the operator will use a paclitaxel-coated DCB (SeQuent Please NEO), sized approximately 1:1 to the reference vessel and covering the prepared segment. DCB delivery within 30 seconds and inflation for 30-60 seconds are recommended when clinically tolerated. DES implantation is permitted for inadequate flow, residual stenosis greater than 30%, substantial recoil, a major dissection, or another procedural reason requiring immediate stenting. Such stenting is part of the assigned DCB-based strategy, not a treatment crossover.
Другие имена:
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Активный компаратор: DES-only PCI group
In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice. |
In the DES-only PCI group, the target or culprit lesion will be treated with a contemporary newer-generation DES according to clinical practice. |
Что измеряет исследование?
Первичные показатели результатов
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Distal FFR at the target or culprit lesion
Временное ограничение: 6 months (±30 days; up to 9 months if necessary)
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Follow-up coronary angiography will be performed at 6 months (±30 days; up to 9 months if necessary), and distal FFR beyond the target or culprit lesion will be measured with a commercially available pressure wire as the primary outcome. |
6 months (±30 days; up to 9 months if necessary)
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Вторичные показатели результатов
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Trans-lesion ΔFFR
Временное ограничение: 6 months (±30 days; up to 9 months if necessary)
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Difference between FFR measured proximal and distal to the target or culprit lesion. |
6 months (±30 days; up to 9 months if necessary)
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Intermediate-term pressure gain (exploratory)
Временное ограничение: 6 months (±30 days; up to 9 months if necessary)
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Change in distal FFR from baseline to follow-up in patients with a preprocedural FFR measurement. |
6 months (±30 days; up to 9 months if necessary)
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Overall stent burden
Временное ограничение: Immediately after index procedure
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Between-group differences in the total number and length of implanted stents |
Immediately after index procedure
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Quantitative coronary angiography (QCA) measures
Временное ограничение: 6 months (±30 days; up to 9 months if necessary)
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Between-group differences in minimum lumen diameter and percentage diameter stenosis of the target or culprit lesion |
6 months (±30 days; up to 9 months if necessary)
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Physiological outcomes by follow-up timing (exploratory)
Временное ограничение: 6-7 months vs. 8-9 months
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Distal FFR and trans-lesion ΔFFR at 6-7 versus 8-9 months. |
6-7 months vs. 8-9 months
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Cardiovascular death
Временное ограничение: From randomization through 12 months
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Number of participants who die from cardiovascular causes, including sudden cardiac death; death due to acute myocardial infarction, heart failure, or cardiogenic shock; other cardiovascular causes; and death of unknown cause without an undisputed noncardiovascular cause. |
From randomization through 12 months
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All-cause death
Временное ограничение: From randomization through 12 months
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Number of participants who die from any cause during follow-up. |
From randomization through 12 months
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Target-Vessel Myocardial Infarction
Временное ограничение: From randomization through 12 months
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Number of participants with myocardial infarction attributed to the target vessel treated during the index procedure. Myocardial infarction is adjudicated using the protocol criteria adapted from the Fourth Universal Definition of Myocardial Infarction. |
From randomization through 12 months
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Nonfatal Myocardial Infarction
Временное ограничение: From randomization through 12 months
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Number of participants with myocardial infarction that does not result in death. Spontaneous and procedure-related myocardial infarctions are included when they meet the protocol criteria adapted from the Fourth Universal Definition of Myocardial Infarction. |
From randomization through 12 months
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Clinically Indicated Target-Lesion Revascularization
Временное ограничение: From randomization through 12 months
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Number of participants undergoing repeat percutaneous coronary intervention of the target lesion or coronary bypass surgery for target-lesion disease when revascularization is clinically indicated. The protocol requires diameter stenosis of at least 50% by quantitative coronary angiography together with corresponding ischemia on functional testing, ischemic electrocardiographic changes at rest, typical ischemic symptoms, a positive invasive physiological test (FFR ≤0.80 or instantaneous wave-free ratio ≤0.89), or diameter stenosis of at least 70% even without another ischemic criterion. |
From randomization through 12 months
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Clinically Indicated Target-Vessel Revascularization
Временное ограничение: From randomization through 12 months
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Number of participants undergoing repeat percutaneous coronary intervention or coronary bypass surgery involving any segment of the target vessel when revascularization is clinically indicated. Clinical indication is determined using the protocol criteria for angiographic stenosis and symptoms, electrocardiographic changes, functional testing, or invasive physiological testing. |
From randomization through 12 months
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Any Revascularization
Временное ограничение: From randomization through 12 months
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Number of participants undergoing any coronary revascularization after the index procedure, including percutaneous coronary intervention or coronary bypass surgery in a target or nontarget vessel, regardless of whether the procedure is classified as clinically indicated. |
From randomization through 12 months
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Definite or Probable Lesion or Stent Thrombosis
Временное ограничение: From randomization through 12 months
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Number of participants with definite or probable thrombosis involving the treated target lesion or an implanted stent. Stent thrombosis is classified according to Academic Research Consortium criteria. For an unstented drug-coated balloon-treated lesion, definite lesion thrombosis is angiographically confirmed thrombus at the treated site with evidence of acute ischemia, or pathologically confirmed thrombus. Probable lesion thrombosis is myocardial infarction associated with documented acute ischemia in the treated lesion's territory, without angiographic confirmation of thrombus or another obvious cause. |
From randomization through 12 months
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Cardiovascular Death or Target-Vessel Myocardial Infarction
Временное ограничение: From randomization through 12 months
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Number of participants who experience cardiovascular death or myocardial infarction attributed to the target vessel, whichever occurs first. Components are defined according to the protocol criteria. |
From randomization through 12 months
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All-Cause Death or Nonfatal Myocardial Infarction
Временное ограничение: From randomization through 12 months
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Number of participants who die from any cause or experience a nonfatal myocardial infarction, whichever occurs first. Myocardial infarction is defined according to the protocol criteria. |
From randomization through 12 months
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Target-Vessel Failure
Временное ограничение: From randomization through 12 months
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Number of participants who experience cardiovascular death, target-vessel myocardial infarction, or clinically indicated target-vessel revascularization, whichever occurs first. |
From randomization through 12 months
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Target-Lesion Failure
Временное ограничение: From randomization through 12 months
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Number of participants who experience cardiovascular death, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization, whichever occurs first. |
From randomization through 12 months
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Clinically Relevant Bleeding
Временное ограничение: From randomization through 12 months
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Number of participants with Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. These categories include overt bleeding requiring clinical evaluation or treatment (type 2), major bleeding (type 3), and probable or definite fatal bleeding (type 5), as defined in the protocol. |
From randomization through 12 months
|
Соавторы и исследователи
Спонсор
Спонсор
Соавторы
Соавторы
Следователи
Следователи
- Главный следователь: Dong Oh OK Kang, MD, PhD, Cardiovascular Center, Korea University Guro Hospital
Публикации и полезные ссылки
Общие публикации
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Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Начало исследования
Первичное завершение (Оцененный)
Первичное завершение
Завершение исследования (Оцененный)
Завершение исследования
Даты регистрации исследования
Первый отправленный
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Первый опубликованный
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее опубликованное обновление
Последнее отправленное обновление, отвечающее критериям контроля качества
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
Другие идентификационные номера исследования
- FLOW-DCB_KUGH
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Deidentified individual participant data may be shared with qualified researchers upon reasonable request and after approval of a submitted research proposal by the principal investigator and/or study steering committee. Data sharing will be conducted in accordance with applicable ethical and regulatory requirements.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .