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THOR IDE-undersøgelsen (THOR)

2. november 2026 opdateret af: 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

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

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.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
155

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Thor Treatment

Treatment with the Thor system
Enhed: Thor laser atherectomy

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

Andre navne:
  • Thor calcium modifikation

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Freedom from Major Adverse Events (MAEs)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Target lesion patency, 30 days
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Philips Clinical & Medical Affairs Global

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
NAMSA
Syntropic

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Elizabeth Genovese, MD, University of Pennsylvania
  • Ledende efterforsker: Pradeep Nair, MD, Cardiovascular Institute of the South (CIS)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
29. oktober 2024

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
1. december 2026

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
1. december 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
7. juni 2023

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
14. juni 2023

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
23. juni 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
2. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 200201

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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