Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I) (ACT I)

20 июня 2017 г. обновлено: Abbott Medical Devices
The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.

Обзор исследования

Статус

Прекращено

Условия

Вмешательство/лечение

Подробное описание

Randomization for ACT 1 employs a 3:1 ratio of CAS versus CEA. A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment.

Тип исследования

Интервенционный

Регистрация (Действительный)

1663

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • Arizona
      • Phoenix, Arizona, Соединенные Штаты, 85054
        • Mayo Clinic
      • Phoenix, Arizona, Соединенные Штаты, 85006
        • St. Luke's Hospital-Phoenix
    • California
      • Mountain View, California, Соединенные Штаты, 94040
        • Fogarty Clinical Research Inc./El Camino Hospital
      • Newport Beach, California, Соединенные Штаты, 92663
        • Hoag Memorial Hospital
      • Orange, California, Соединенные Штаты, 92868
        • St. Joseph Hospital
      • San Diego, California, Соединенные Штаты, 92120
        • Kaiser Foundation Hospital-San Diego
    • District of Columbia
      • Washington, D.C., District of Columbia, Соединенные Штаты, 20010
        • Washington Hospital Center
    • Florida
      • Miami, Florida, Соединенные Штаты, 33176
        • Baptist Cardiac and Vascular Institute
    • Georgia
      • Atlanta, Georgia, Соединенные Штаты, 30309
        • Piedmont Hospital
      • Gainesville, Georgia, Соединенные Штаты, 30501
        • Northeast Georgia Medical Center
    • Hawaii
      • Honolulu, Hawaii, Соединенные Штаты, 96817
        • Hawaii Permanente Medical Group - Kaiser
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Соединенные Штаты, 60611
        • Northwestern University Memorial Hospital
      • Springfield, Illinois, Соединенные Штаты, 62701
        • St. John's Hospital and Memorial Medical Center/ Prairie Heart Cooperative
    • Indiana
      • Fort Wayne, Indiana, Соединенные Штаты, 46805
        • Parkview Hospital
    • Kentucky
      • Lexington, Kentucky, Соединенные Штаты, 40503
        • Central Baptist Hospital
      • Louisville, Kentucky, Соединенные Штаты, 40292
        • University of Louisville
    • Louisiana
      • Lafayette, Louisiana, Соединенные Штаты, 70506
        • Cardiovascular Institute of the South
      • New Orleans, Louisiana, Соединенные Штаты, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, Соединенные Штаты, 21224
        • Johns Hopkins Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, Соединенные Штаты, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, Соединенные Штаты, 48201
        • Harper University Hospital/Detroit Medical Center
      • Flint, Michigan, Соединенные Штаты, 48507
        • McLaren Regional Medical Center
      • Royal Oak, Michigan, Соединенные Штаты, 48073
        • William Beaumont Hospital
    • Missouri
      • Saint Louis, Missouri, Соединенные Штаты, 63141
        • St. John's Mercy Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, Соединенные Штаты, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, Соединенные Штаты, 08103
        • Our Lady of Lourdes Medical Center
    • New York
      • Albany, New York, Соединенные Штаты, 12208
        • Albany Medical Center
      • Buffalo, New York, Соединенные Штаты, 14209
        • Millard Fillmore Hospital
      • New York, New York, Соединенные Штаты, 10021
        • Lenox Hill Hospital
      • New York, New York, Соединенные Штаты, 10016
        • NYU Medical Center
      • New York, New York, Соединенные Штаты, 10021
        • Columbia Presbyterian Hospital
      • Rochester, New York, Соединенные Штаты, 14623
        • University of Rochester-Strong Memorial Hospital
      • Roslyn, New York, Соединенные Штаты, 11576
        • St. Francis Hospital
    • North Carolina
      • Durham, North Carolina, Соединенные Штаты, 27609
        • Duke University Medical Center
      • Raleigh, North Carolina, Соединенные Штаты, 27610
        • Wakemed Health and Hospital
      • Winston-Salem, North Carolina, Соединенные Штаты, 27103
        • Forsyth Medical Center
    • Ohio
      • Cleveland, Ohio, Соединенные Штаты, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, Соединенные Штаты, 43214
        • Riverside Methodist Hospital
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97239
        • Oregon Health and Science University Stroke Center
    • Pennsylvania
      • Beaver, Pennsylvania, Соединенные Штаты, 15009
        • Heritage Valley Health System
      • Harrisburg, Pennsylvania, Соединенные Штаты, 17110
        • Harrisburg Hospital / Pinnacle Health
      • Philadelphia, Pennsylvania, Соединенные Штаты, 19104
        • Hospital of The University of Pennsylvania
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
        • University of Pittsburgh Medical Center (UPMC)
      • Pittsburgh, Pennsylvania, Соединенные Штаты, 15232
        • University of Pittsburgh Physicians Division of Vascular Surgery/Shadyside Medical
      • Washington, Pennsylvania, Соединенные Штаты, 15301
        • Allegheny General Hospital
      • Wyomissing, Pennsylvania, Соединенные Штаты, 19610
        • St. Joseph's Medical Center/Berks Cardiologists
    • South Carolina
      • Columbia, South Carolina, Соединенные Штаты, 29204
        • Providence Hospital-SC
    • South Dakota
      • Sioux Falls, South Dakota, Соединенные Штаты, 57108
        • North Central Heart Institute
    • Tennessee
      • Germantown, Tennessee, Соединенные Штаты, 38138
        • The Stern Cardiovascular Center/Methodist Germantown Hospital
      • Kingsport, Tennessee, Соединенные Штаты, 37660
        • Wellmont Holston Valley Medical Center
      • Knoxville, Tennessee, Соединенные Штаты, 37934
        • Mercy Medical West/Turkey Creek Medical Center
    • Texas
      • Austin, Texas, Соединенные Штаты, 78756
        • Heart Hospital of Austin
      • Austin, Texas, Соединенные Штаты, 78705
        • Westlake Medical Center/Seton Heart Institute
      • Dallas, Texas, Соединенные Штаты, 75231
        • Presbyterian Hospital of Dallas
      • Dallas, Texas, Соединенные Штаты, 75216
        • Dallas Veteran's Administration Medical Center
      • Houston, Texas, Соединенные Штаты, 77030
        • St. Luke's Episcopal Hospital
    • Virginia
      • Norfolk, Virginia, Соединенные Штаты, 23507
        • Chesapeake General Hospital/Sentara Norfolk General Hospital
      • Richmond, Virginia, Соединенные Штаты, 23226
        • St. Mary's Hospital / Virginia Cardiovascular Specilists
    • Washington
      • Spokane, Washington, Соединенные Штаты, 99204
        • Deaconess Medical Center
    • Wisconsin
      • Madison, Wisconsin, Соединенные Штаты, 53792
        • University of Wisconsin
      • Milwaukee, Wisconsin, Соединенные Штаты, 53215
        • St. Luke's Medical Center - Milwaukee

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 79 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. The subject must be > 18 and < 80 years of age.
  2. Female subjects of child bearing potential must have a documented negative pregnancy test within 30 days prior to the study procedure.
  3. Subject must be asymptomatic, defined as no stroke or Transient Ischemic Attack [(TIA);(hemispheric or ocular)] within the 180 days prior to the procedure. Subjects who have experienced these neurological symptoms prior to the 180 day pre-procedure window will be eligible for enrollment. An independent study neurologist or independent study neurosurgeon must confirm the subject's neurological status.
  4. Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted after the procedure.
  5. The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local institutional review board (IRB).
  6. The subject must agree to return for all required follow-up visits.
  7. Subject has a discrete lesion located in the internal carotid artery (ICA); the contiguous common carotid artery (CCA) may be involved.
  8. Carotid stenosis ≥ 70% and ≤ 99% by carotid ultrasound or ≥ 70% and ≤ 99% stenosis (visual estimate) by angiography, without significant (> 60% by ultrasound or angiography) ICA/CCA contralateral stenosis.

  9. Target ICA vessel diameter must be visually estimated to be:

    > 2.5 mm and < 7.0 for the Emboshield Pro or for the Emboshield NAV6, > 2.8 mm and < 6.2 for the Emboshield Gen 3 And > 4.0 mm and < 9.0 mm for the Xact stent treatment segment. An untreated contralateral ICA may be used for visual estimation when a highly stenosed lesion makes measurement of the target vessel inaccurate.

  10. Based on the subject's anatomy, the Investigator should expect to successfully deliver the stent to the target lesion (absence of extreme tortuosity, etc.).
  11. De novo target lesion that can be treated with a single stent.

Exclusion Criteria:

Each potential subject must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.

  1. Subject is symptomatic and has had a stroke or exhibited TIA (hemispheric or ocular) within 180 days prior to randomization, which has been confirmed by an independent study neurologist or independent study neurosurgeon.
  2. Subject is participating in another drug or device trial (IND or IDE) that has not completed the primary endpoint or that may potentially confound the results of this trial. Subject may be enrolled only once in this trial and may not participate in any other clinical trial during a 1-year period post-index procedure.
  3. Subject has inability to understand and cooperate with study procedures or provide informed consent.
  4. Subject has had an intracranial hemorrhage or hemorrhagic stroke within 1-year prior the index procedure.
  5. Subject has dementia or has a neurological illness that may confound the neurological evaluation.
  6. Subject has had a known untoward reaction to anesthesia or contrast media not able to be overcome by pre-treatment with medications.
  7. Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and Clopidogrel/Ticlopidine.
  8. Subject has Hemoglobin (Hgb) less than 10 gm/dL, platelet count <100,000/mm3 or >500,000/mm3, or known heparin associated thrombocytopenia.
  9. Subject has an active bleeding diathesis or coagulopathy, or will refuse blood transfusions.
  10. Subject has had a GI bleed that would interfere with antiplatelet therapy.
  11. Subject has known cardiac sources of emboli, including paroxysmal or sustained atrial fibrillation (treated or untreated).
  12. Subject has had an myocardial infarction (MI) within the previous 30 days.
  13. Subject has any condition that limits their anticipated survival to less than 3 years.

  14. Subject is a high risk surgical candidate defined as the presence of any one or more of a following medical conditions:

    1. Two or more proximal diseased coronary arteries of > 70% stenosis that have not or cannot be revascularized or < 30 days since revascularization.
    2. Ejection fraction < 30% or New York Heart Association (NYHA) heart failure functional class 3 or higher.
    3. Unstable angina, defined as angina at rest with ECG changes.
    4. On a list for major organ transplant or is being evaluated for such.
    5. Known history of respiratory insufficiency, forced expiratory volume (FEV1) < 30% (predicted).
    6. Chronic renal insufficiency (serum creatinine >2.5 mg/dL).
    7. Uncontrolled diabetes defined as fasting glucose > 400 mg/dL.
    8. Concurrent requirement for any invasive procedure 30 days pre- or post-procedure.
    9. Age ≥ 80 years.

  15. Subject may be considered a non-surgical candidate for CEA as a result of one or more anatomic conditions or features which preclude normal surgical access or a high surgical risk because of the presence of any one or more anatomic conditions that present an increased potential for adverse events. These subjects are not eligible for enrollment.

    1. Subject has had radiation treatment to the neck.
    2. Subject has had a radical neck dissection.
    3. Surgically inaccessible lesions (i.e., lesions extending above the level of C2).
    4. Spinal immobility - inability to flex neck beyond neutral or kyphotic deformity.
    5. Presence of carotid artery dissection, aneurysm, pseudoaneurysm, arteritis or fibromuscular dysplasia (FMD) in the target vessel.
    6. Hemodynamically significant (>60%) stenosis of the right or left common carotid artery (LCCA/RCCA) below the clavicle.
    7. Presence of tracheostomy stoma.
    8. Contralateral laryngeal nerve paralysis.
    9. Previous carotid endarterectomy, extracranial-intracranial or carotid subclavian bypass procedure ipsilateral to the carotid stenosis.
    10. Severe hypertension (defined as blood pressure > Systolic of 180 mm Hg and/or a diastolic of 110 mm Hg) not adequately controlled by anti-hypertensive therapy at the time of study entry.
  16. Severe vascular disease including tortuosity and/or occlusive disease that would preclude the safe introduction of a guiding catheter/sheath, cerebral protection device, balloon catheter, stent delivery system or stent placement. Severe tortuosity is defined as 2 or more >90 degree bend points within 3cm of the target stenosis. One of these bends will be considered to be present if the ICA branches from the CCA at a 90 degree angle. This includes aortic arch anatomy that is unacceptable for carotid stent placement.
  17. Intraluminal filling defect thought to represent thrombus.
  18. Excessive calcification: defined as fluoroscopic evidence of calcium that extends circumferentially around the target lesion and includes the majority of the atherosclerotic plaque.
  19. Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
  20. The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) prior to stent placement.
  21. Significant (> 60%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off.
  22. Presence of a previously placed intravascular stent in the ipsilateral carotid distribution.
  23. Cerebral aneurysm (symptomatic or > 10 mm) or arteriovenous malformation (AVM) of the cerebral vasculature.
  24. Bilateral carotid stenosis (ICA/CCA contralateral stenosis > 60% by ultrasound or angiography).

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Другой
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: 1

CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
Устройство: Carotid artery stenting with filter (interventional)
Carotid artery stenting with filter (interventional)
Активный компаратор: 2

CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.
Процедура: Carotid artery endarterectomy (surgical)
Carotid artery endarterectomy (surgical)

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Временное ограничение
Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.
Временное ограничение: 0 to 365 days
0 to 365 days

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Acute Device Success: Xact Carotid Stent
Временное ограничение: On day 0 after index procedure
Defined as attainment of final residual diameter stenosis of < 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.
On day 0 after index procedure
Acute Device Success: Embolic Protection Device System
Временное ограничение: On day 0 after index procedure
Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.
On day 0 after index procedure
Procedural Success
Временное ограничение: 0 to 30 days post procedure
Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.
0 to 30 days post procedure
Composite Morbidity Measure
Временное ограничение: 0 to 30 Days Post-procedure
A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.
0 to 30 Days Post-procedure
Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
Временное ограничение: 0 to 180 days
Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 180 days
Freedom From Clinically Indicated Target Lesion Revascularization
Временное ограничение: 0 to 365 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 365 days
Freedom From Clinically Indicated Target Lesion Revascularization
Временное ограничение: 0 to 730 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 730 days
Freedom From Clinically Indicated Target Lesion Revascularization
Временное ограничение: 0 to 1095 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 1095 days
Freedom From Clinically Indicated Target Lesion Revascularization
Временное ограничение: 0 to 1460 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 1460 days
Freedom From Clinically Indicated Target Lesion Revascularization
Временное ограничение: 0 to 1825 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 1825 days
Freedom From Ipsilateral Stroke
Временное ограничение: 31 to 365 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 365 days
Freedom From Ipsilateral Stroke
Временное ограничение: 31 to 730 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 730 days
Freedom From Ipsilateral Stroke
Временное ограничение: 31 to 1095 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 1095 days
Freedom From Ipsilateral Stroke
Временное ограничение: 31 to 1460 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 1460 days
Freedom From Ipsilateral Stroke
Временное ограничение: 31 to 1825 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 1825 days
Freedom From Mortality
Временное ограничение: 0 to 365 days
0 to 365 days
Freedom From Mortality
Временное ограничение: 0 to 730 days
0 to 730 days
Freedom From Mortality
Временное ограничение: 0 to 1095 days
0 to 1095 days
Freedom From Mortality
Временное ограничение: 0 to 1460 days
0 to 1460 days
Freedom From Mortality
Временное ограничение: 0 to 1825 days
0 to 1825 days
Freedom From All Stroke
Временное ограничение: 0 to 365 days
0 to 365 days
Freedom From All Stroke
Временное ограничение: 0 to 730 days
0 to 730 days
Freedom From All Stroke
Временное ограничение: 0 to 1095 days
0 to 1095 days
Freedom From All Stroke
Временное ограничение: 0 to 1460 days
0 to 1460 days
Freedom From All Stroke
Временное ограничение: 0 to 1825 days
0 to 1825 days
Death (Non-Hierarchical)
Временное ограничение: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
All Stroke (Non-Hierarchical)
Временное ограничение: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Myocardial Infarction (MI) (Non-Hierarchical)
Временное ограничение: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
Временное ограничение: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death or Stroke (Hierarchical)
Временное ограничение: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death or Major Stroke (Hierarchical)
Временное ограничение: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years
Временное ограничение: 0 to 5 years
0 to 5 years

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Abbott Medical Devices

Следователи

  • Главный следователь: Jon Matsumura, MD, University of Wisconsin, Madison

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 апреля 2005 г.

Первичное завершение (Действительный)

1 марта 2013 г.

Завершение исследования (Действительный)

1 марта 2013 г.

Даты регистрации исследования

Первый отправленный

1 апреля 2005 г.

Впервые представлено, что соответствует критериям контроля качества

1 апреля 2005 г.

Первый опубликованный (Оценивать)

4 апреля 2005 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

19 июля 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

20 июня 2017 г.

Последняя проверка

1 июня 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • AVD-640-0052

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. .

Искать похожие исследования

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

CROs by country

CROs in Iran

Заболевания

Редкие заболевания

Медикаментозные вмешательства

Пищевые добавки

Спонсор / Соавторы

Места

Подписаться