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L'étude THOR IDE (THOR)

2 novembre 2026 mis à jour par: Philips Clinical & Medical Affairs Global

The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).

The main question[s] it aims to answer are:

  • Is the Thor system safe in treating these lesions
  • Does the Thor system work to treat these lesions

Participants will:

  • Receive treatment with the Thor system
  • Have follow-up visits at Discharge, 30 days, 6 months, and 12 months

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Up to 30 sites in the U.S. will be selected to do this study.

Patients with pain in their legs when walking and/or resting that is due to lack of blood flow to their legs may be able to join the study. To join the study patients must also have blockages in their leg arteries that meet the study criteria.

Before the Thor procedure, patients will have a screening visit that includes a review of their medical records, questions about their medical history and medications taken for blood thinning or circulation, a physical examination of their legs, a test to check the blood flow in their legs (by checking arm and leg blood pressures), blood tests, and a pregnancy test if they are a female able to have children. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

All patients in the study will have treatment with the Thor system. There is no "control group" (a group of patients that receives only standard treatment or receives no treatment at all) in this study. During the procedure, the doctor will take x-ray pictures of the leg arteries. They may also use other treatments such as angioplasty balloons, drug-coated balloons, stents, and filters that collect blood clots, if needed.

Patients treated with the Thor system will be watched until they are ready to go home or up to 24 hours after the procedure if they do not go home right away. Before they go home they will have a test to check the blood flow to their legs (by checking arm and leg blood pressures) and be checked for any adverse events.

Patients will return for visits at 30 days, 6 months, and 12 months after the Thor procedure. At these visits patients will be asked questions about their medical history and medications taken for blood thinning or circulation, have a physical examination of their legs, have a test to check the blood flow in their treated leg (by checking arm and leg blood pressures), have an ultrasound of their treated leg, and be checked for any adverse events. Patients will also answer questions about any trouble they have had with walking in the last week and their overall quality of life.

It will take up to 24 months (2 years) to enroll all of the patients in the study. Patients who join the study will be in the study for about 12 months (1 year) and will have all of the visits with their doctor that they would normally have for their PAD.

Type d'étude

Interventionnel

Inscription (Estimé)

155

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • California
      • St. Helena, California, États-Unis, 94574
        • Retiré
        • St. Helena Hospital
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • Recrutement
        • Rocky Mountain Regional VA Medical Center
        • Chercheur principal:
          • Bilal Aijaz, MD
        • Contact:
        • Sous-enquêteur:
          • Stephen Waldo, MD
        • Contact:
    • Florida
      • Bradenton, Florida, États-Unis, 34205
      • Tallahassee, Florida, États-Unis, 32308
        • Recrutement
        • Tallahassee Research Institute
        • Chercheur principal:
          • William Dixon
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • John Katopodis
      • Winter Park, Florida, États-Unis, 32792
        • Recrutement
        • Guardian Research Organization
        • Chercheur principal:
          • Ashish Gupta, MD
        • Contact:
        • Sous-enquêteur:
          • Sandeep Bajaj
        • Contact:
          • Tiffany King
    • Iowa
      • Davenport, Iowa, États-Unis, 52807
    • Louisiana
      • Houma, Louisiana, États-Unis, 70360
        • Recrutement
        • Cardiovascular Institute of the South
        • Chercheur principal:
          • Craig Walker, MD
        • Sous-enquêteur:
          • Matthew Finn, MD
        • Sous-enquêteur:
          • Pradeep Nair, MD
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • McCall Walker, MD
      • Lafayette, Louisiana, États-Unis, 70503
        • Recrutement
        • Cardiovascular Institute of the South
        • Chercheur principal:
          • Ankur Lodha, MD
        • Contact:
        • Sous-enquêteur:
          • Amit Amin, MD
        • Sous-enquêteur:
          • David Tadin, MD
    • Maine
      • Portland, Maine, États-Unis, 04106
        • Recrutement
        • The Vascular Care Group
        • Sous-enquêteur:
          • Todd Lancaster, MD
        • Sous-enquêteur:
          • Daniel Gorin, MD
        • Sous-enquêteur:
          • Christopher Kwolek, MD
        • Contact:
        • Chercheur principal:
          • Nathan Aranson, MD
    • Massachusetts
      • Fall River, Massachusetts, États-Unis, 02720
        • Recrutement
        • Southcoast Hospitals/Charlton Memorial Hospital
        • Chercheur principal:
          • Richard Pin, MD
        • Contact:
        • Sous-enquêteur:
          • Mark Perry, MD
        • Sous-enquêteur:
          • Brandon Sumpio, MD
      • Leominster, Massachusetts, États-Unis, 04153
        • Actif, ne recrute pas
        • Vascular Breakthroughs
    • Michigan
      • Detroit, Michigan, États-Unis, 48202
        • Recrutement
        • Henry Ford Hospital
        • Sous-enquêteur:
          • Pedro Villablanca, MD
        • Sous-enquêteur:
          • Khaldoon Alaswad, MD
        • Contact:
        • Sous-enquêteur:
          • Gerald Koenig, MD
        • Sous-enquêteur:
          • Vikas Aggarwal, MD
        • Sous-enquêteur:
          • Mohammad Alqarqaz, MD
        • Sous-enquêteur:
          • Herbert Aronow, MD
        • Chercheur principal:
          • Kyle Markel, MD
        • Contact:
      • Detroit, Michigan, États-Unis, 22201
        • Recrutement
        • Henry Ford St John Hospital
        • Contact:
        • Chercheur principal:
          • Thomas Davis, Dr
        • Contact:
    • New Jersey
      • Browns Mills, New Jersey, États-Unis, 08015
        • Recrutement
        • Deborah Heart and Lung Center
        • Chercheur principal:
          • Richard Kovach, MD
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Gregory Domer, MD
      • New Brunswick, New Jersey, États-Unis, 08901
        • Recrutement
        • Heart and Vascular Institute of Central Jersey
        • Chercheur principal:
          • Ramzan Zakir, MD
        • Contact:
      • Vineland, New Jersey, États-Unis, 08360
        • Recrutement
        • Atlantic Medical Imaging of New jersey
        • Chercheur principal:
          • Micah Watts, MD
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Nicholas Petruzzi, MD
        • Sous-enquêteur:
          • Ramkrishna Patel, MD
    • New York
      • New York, New York, États-Unis, 10029
        • Recrutement
        • Mount Sinai Hospital
        • Chercheur principal:
          • Prakash Krishnan, MD
        • Sous-enquêteur:
          • David Song, MD
        • Contact:
        • Sous-enquêteur:
          • Vishal Kapur, MD
        • Sous-enquêteur:
          • Raman Sharma
        • Contact:
      • New York, New York, États-Unis, 10029
        • Recrutement
        • New York Presbyterian Hospital/Columbia University Irving Medical Center
        • Contact:
        • Chercheur principal:
          • Virendra Patel, MD
        • Sous-enquêteur:
          • Thomas O'Donnell, MD
        • Sous-enquêteur:
          • Nicholas Morrissey
        • Sous-enquêteur:
          • Danielle Bajakian
        • Contact:
    • North Carolina
      • Cary, North Carolina, États-Unis, 27518
        • Recrutement
        • Vascular Solutions of North Carolina
        • Contact:
        • Contact:
        • Chercheur principal:
          • Sid Rao, MD
    • Ohio
      • Fairborn, Ohio, États-Unis, 45324
        • Recrutement
        • Premier Cardiovascular Institute
        • Chercheur principal:
          • Sagger Mawri, MD
        • Sous-enquêteur:
          • James Pan, MD
        • Contact:
        • Contact:
    • Oklahoma
      • Bartlesville, Oklahoma, États-Unis, 74006
        • Recrutement
        • Ascension St. John
        • Contact:
        • Chercheur principal:
          • Anderson Merhle, MD
        • Sous-enquêteur:
          • Michael Megaly, MD
        • Contact:
          • Numéro de téléphone: 918.332.3616
    • Pennsylvania
      • Mechanicsburg, Pennsylvania, États-Unis, 17050
        • Recrutement
        • UPMC
        • Contact:
        • Chercheur principal:
          • William Bachinsky, Dr
        • Contact:
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Recrutement
        • Hospital of the University of Pennsylvania
        • Contact:
        • Chercheur principal:
          • Elizabeth Genovese, MD
        • Sous-enquêteur:
          • Shang Loh, MD
        • Sous-enquêteur:
          • Alexander Fairman, MD
        • Sous-enquêteur:
          • Douglas Troutman, MD
      • Wynnewood, Pennsylvania, États-Unis, 19096
        • Recrutement
        • Lankenau Institute for Medical Research
        • Contact:
          • Lynn Sher
          • Numéro de téléphone: 484.476.8581
          • E-mail: SherL@mlhs.org
        • Chercheur principal:
          • Antonis Pratsos, MD
        • Sous-enquêteur:
          • Manju Jayanna, MD
        • Sous-enquêteur:
          • Sarang Mangalmurti, MD
        • Contact:
          • Lucy Delp
          • Numéro de téléphone: 484.476.8512
          • E-mail: delpl@mlhs.org
    • Rhode Island
      • Providence, Rhode Island, États-Unis, 02905
        • Recrutement
        • The Miriam Hospital
        • Chercheur principal:
          • Peter Soukas, MD
        • Contact:
        • Sous-enquêteur:
          • Pieter de Klerk, MD
    • Tennessee
      • Chattanooga, Tennessee, États-Unis, 37421
        • Recrutement
        • Vascular Institute of Chattanooga
        • Contact:
        • Sous-enquêteur:
          • William Harris, DO
        • Chercheur principal:
          • Chris LeSar, MD
    • Texas
      • Dallas, Texas, États-Unis, 75390
      • Plano, Texas, États-Unis, 75093
        • Recrutement
        • Baylor, Scott & White, The Heart Hospital
        • Chercheur principal:
          • Sameh Sayfo, MD
        • Sous-enquêteur:
          • Chadi Dib, MD
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Tony Das, MD
    • Virginia
      • Norfolk, Virginia, États-Unis, 23507
        • Recrutement
        • Sentara Health Research Center
        • Chercheur principal:
          • David Dexter, MD
        • Contact:
        • Sous-enquêteur:
          • Animesh Rathore, MD
        • Sous-enquêteur:
          • Priyam Vyas, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Patient age is ≥18 years
  • Patient agrees to participate and to comply with the protocol by signing an IRB approved patient consent form
  • Patient is able to walk unassisted or with non-motorized assistive devices
  • Patient has PAD with documented Rutherford Class 2-4 of the target limb
  • Anticipated life expectancy >12 months, in the opinion of the investigator at the time of enrollment.

Angiographic Inclusion Criteria:

  • Patient has de novo atherosclerotic disease of the native SFA and/or the popliteal arteries
  • Target lesion has ≥70% diameter stenosis by investigator via visual assessment
  • Target lesion length ≤150mm. Total treatment zone may not exceed 150mm, and may include one or more lesions.
  • Chronic total occlusion lesion length is <100mm of the total ≤150mm target lesion
  • Minimum reference vessel diameter (RVD) 4.0mm by visual estimate
  • Target lesion crossed and intraluminal guidewire placement confirmed; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations
  • At least one patent tibial vessel (defined as <50% stenosis) with runoff to the foot
  • Target lesion has moderate to severe calcification graded using the Peripheral Academic Research Consortium (PARC) criteria

Exclusion Criteria:

  • Patient has active infection requiring antibiotic therapy
  • Stenting planned within the target lesion
  • Known positive for COVID-19 within the last 2 weeks and actively symptomatic
  • Pregnant (positive pregnancy test) or currently breast feeding
  • Evidence of Acute Limb Ischemia in the target limb within 7 days prior to procedure
  • Cerebrovascular accident (CVA) <60 days prior to procedure
  • Myocardial infarction <60 days prior to procedure
  • History of unstable coronary artery disease or other uncontrollable comorbidity resulting in hospitalization within the last 60 days prior to baseline screening
  • Known contraindication to aspirin, or antiplatelet/anti-coagulant therapies required for procedure/follow-up
  • Known allergy to contrast media that cannot adequately be premedicated prior to study procedure
  • History of Thrombophilia, Heparin-induced Thrombocytopenia (HIT), or Heparin-induced Thrombotic Thrombocytopenia Syndrome (HITTS)
  • Serum creatinine ≥2.5mg/dL (unless dialysis-dependent) tested within 30 days prior to procedure
  • Planned lower limb major amputation (above the ankle)
  • Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned on target limb for within 30 days following index procedure, with the exception of diagnostic angiography
  • Currently participating in any investigational device or drug clinical trial that, in the opinion of the investigator, will interfere with the conduct of the current study
  • The use of specialty balloons, re-entry or additional atherectomy devices is required for treatment of the target lesion.

Angiographic Exclusion Criteria:

  • Subject has significant stenosis (>50% stenosis) or occlusion of inflow tract before target treatment zone (e.g. iliac or common femoral) not successfully treated.
  • Subject requires treatment of a peripheral lesion on the ipsilateral limb distal to the target site at the time of the index procedure.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Thor Treatment

Treatment with the Thor system
Dispositif: Thor laser atherectomy

Treatment of de novo calcified lesions with laser atherectomy and calcium modification using the Thor system

Autres noms:
  • Thor calcium modification

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Freedom from Major Adverse Events (MAEs)
Délai: 30 Days

Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
30 Days
Procedural Success
Délai: At completion of the procedure

Defined as residual diameter stenosis ≤50% at the end of the procedure as determined by angiographic core lab
At completion of the procedure

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Target lesion patency, 30 days
Délai: 30 days

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
30 days
Target lesion patency, 6 months
Délai: 6 months

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
6 months
Target lesion patency, 12 months
Délai: 12 months

Defined as freedom from CD-TLR and freedom from ≥50% restenosis as determined by duplex ultrasound (DUS) or angiogram
12 months
Clinically-driven target lesion revascularization
Délai: Through 12 months

Defined as repeat revascularization procedure of the target lesion if PSVR is ≥2.5 by DUS or if angiography shows a percent diameter stenosis >50% and there are worsening clinical symptoms, worsening Rutherford Clinical Category or ABI that is clearly referable to the target lesion.
Through 12 months
Technical success
Délai: Peri-procedural

Defined as the ability to deliver the Thor system and achieve residual diameter stenosis ≤50% after treatment with Thor and prior to adjunctive PTA, as confirmed by independent core laboratory assessments of angiographic images
Peri-procedural
Frequency of peri-procedural adverse events
Délai: Within 24 hours of the procedure

Defined as frequency of adverse events related to the investigational device (Thor system)
Within 24 hours of the procedure
Adjunctive devices used with the Thor system
Délai: Peri-procedural

Defined as the use of other devices including angioplasty balloons, drug coated balloons, bailout stents, embolic filters
Peri-procedural
Target Limb Ankle-Brachial Index (ABI) change, Discharge
Délai: Discharge or up to 24 hours after the procedure

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at discharge compared to the baseline (Screening) value
Discharge or up to 24 hours after the procedure
Target Limb Ankle-Brachial Index (ABI) change, 30 days
Délai: 30 days

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 30 days compared to the baseline (Screening) value
30 days
Target Limb Ankle-Brachial Index (ABI) change, 6 months
Délai: 6 months

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 6 months compared to the baseline (Screening) value
6 months
Target Limb Ankle-Brachial Index (ABI) change, 12 months
Délai: 12 months

Defined as the change in blood pressure in the upper limb (arm) and lower limb (leg or toes) at 12 months compared to the baseline (Screening) value
12 months
Rutherford Classification change, 30 days
Délai: 30 days

Defined as the change in Rutherford classification at 30 days compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
30 days
Rutherford Classification change, 6 months
Délai: 6 months

Defined as the change in Rutherford classification at 6 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
6 months
Rutherford Classification change, 12 months
Délai: 12 months

Defined as the change in Rutherford classification at 12 months compared to the baseline (Screening) value. Rutherford Classification is a staging system to describe reduced blood flow in the lower limb. Rutherford Classifications values range from the least severe (asymptomatic) which is scored a 0 to the most severe (ulceration or gangrene) which is scored a 6.
12 months
Freedom from Major Adverse Events (MAEs)
Délai: Through 12 months

Defined as freedom from MAEs including all-cause mortality, clinically driven target lesion revascularization (CD-TLR), unplanned target limb major amputation, and perforations, flow-limiting dissections, and symptomatic distal embolizations that require an intervention to resolve
Through 12 months
Change in Short Form Health Survey (SF-36) score, 30 days
Délai: 30 days

Defined as the change in SF-36 score at 30 days compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
30 days
Change in Short Form Health Survey (SF-36) score, 6 months
Délai: 6 months

Defined as the change in SF-36 score at 6 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
6 months
Change in Short Form Health Survey (SF-36) score, 12 months
Délai: 12 months

Defined as the change in SF-36 score at 12 months compared to the baseline (Screening) value. The SF-36 is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
12 months
Change in Walking Impairment Questionnaire (WIQ) score, 30 days
Délai: 30 days

Defined as the change in WIQ score at 30 days compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
30 days
Change in Walking Impairment Questionnaire (WIQ) score, 6 months
Délai: 6 months

Defined as the change in WIQ score at 6 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
6 months
Change in Walking Impairment Questionnaire (WIQ) score, 12 months
Délai: 12 months

Defined as the change in WIQ score at 12 months compared to the baseline (Screening) value. The WIQ measures self-reported walking impairment, walking distance, walking speed, and stair-climbing ability. In the WIQ there are 21 questions to rate the degree of difficulty with the walking and stair climbing elements. The response for each question is on a 0 to 4 scale, where 0 represents the inability to walk or climb stairs, and 4 represents no difficulty.
12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Philips Clinical & Medical Affairs Global

Collaborateurs

NAMSA
Syntropic

Les enquêteurs

  • Chercheur principal: Elizabeth Genovese, MD, University of Pennsylvania
  • Chercheur principal: Pradeep Nair, MD, Cardiovascular Institute of the South (CIS)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 octobre 2024

Achèvement primaire (Estimé)

1 décembre 2026

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

7 juin 2023

Première soumission répondant aux critères de contrôle qualité

14 juin 2023

Première publication (Réel)

23 juin 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 200201

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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