Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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 giugno 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1663

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 79 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Dispositivo: Carotid artery stenting with filter (interventional)
Carotid artery stenting with filter (interventional)
Comparatore attivo: 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.
Procedura: Carotid artery endarterectomy (surgical)
Carotid artery endarterectomy (surgical)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: 0 to 365 days
0 to 365 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acute Device Success: Xact Carotid Stent
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 0 to 365 days
0 to 365 days
Freedom From Mortality
Lasso di tempo: 0 to 730 days
0 to 730 days
Freedom From Mortality
Lasso di tempo: 0 to 1095 days
0 to 1095 days
Freedom From Mortality
Lasso di tempo: 0 to 1460 days
0 to 1460 days
Freedom From Mortality
Lasso di tempo: 0 to 1825 days
0 to 1825 days
Freedom From All Stroke
Lasso di tempo: 0 to 365 days
0 to 365 days
Freedom From All Stroke
Lasso di tempo: 0 to 730 days
0 to 730 days
Freedom From All Stroke
Lasso di tempo: 0 to 1095 days
0 to 1095 days
Freedom From All Stroke
Lasso di tempo: 0 to 1460 days
0 to 1460 days
Freedom From All Stroke
Lasso di tempo: 0 to 1825 days
0 to 1825 days
Death (Non-Hierarchical)
Lasso di tempo: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
All Stroke (Non-Hierarchical)
Lasso di tempo: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Myocardial Infarction (MI) (Non-Hierarchical)
Lasso di tempo: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
Lasso di tempo: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death or Stroke (Hierarchical)
Lasso di tempo: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death or Major Stroke (Hierarchical)
Lasso di tempo: ≤ 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
Lasso di tempo: 0 to 5 years
0 to 5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Abbott Medical Devices

Investigatori

  • Investigatore principale: Jon Matsumura, MD, University of Wisconsin, Madison

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 aprile 2005

Completamento primario (Effettivo)

1 marzo 2013

Completamento dello studio (Effettivo)

1 marzo 2013

Date di iscrizione allo studio

Primo inviato

1 aprile 2005

Primo inviato che soddisfa i criteri di controllo qualità

1 aprile 2005

Primo Inserito (Stima)

4 aprile 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 luglio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 giugno 2017

Ultimo verificato

1 giugno 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AVD-640-0052

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Lithuania

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi