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Merit WRAPSODY AV Access Efficacy Study (WAVE) (WAVE)

14. maj 2026 opdateret af: Merit Medical Systems, Inc.

Prospektiv, randomiseret, kontrolleret, multicenterundersøgelse, der sammenligner Merit WRAPSODY™ endovaskulær stentgraft med perkutan transluminal angioplastik til behandling af venøs udstrømningskredsløbsstenose eller okklusion hos hæmodialysepatienter. WAVE-undersøgelsen

Formålet med undersøgelsen er at demonstrere sikkerheden og effektiviteten af ​​Merit WRAPSODY endovaskulær stentgraft til behandling af stenose eller okklusion i udløbskredsløbet for dialyseadgang.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

357

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Brasilien
      • Brasília, Brasilien
        • Instituto Santa Marta De Ensino E Pesquisa
      • Recife, Brasilien
        • Real Hospital Português de Beneficência em Pernambuco
      • Rio de Janeiro, Brasilien
        • Hospital Universitário Pedro Ernesto
      • São Paulo, Brasilien
        • Instituto Dante Pazzanese de Cardiologia
  • Canada
      • Toronto, Canada
        • Toronto General Hospital
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B15 2TH
        • Queen Elizabeth Hospital
      • Dorchester, Det Forenede Kongerige
        • Dorset County Hospital
      • London, Det Forenede Kongerige, E1 1FR
        • Royal London Hospital
      • Oxford, Det Forenede Kongerige, OX3 7LE
        • Churchill Hospital
      • Stevenage, Det Forenede Kongerige, SG1 4AB
        • Lister Hospital
  • Forenede Stater
    • Arizona
      • Tempe, Arizona, Forenede Stater, 85281
        • Southwest Kidney institute (SKI) Vascular Center
      • Tucson, Arizona, Forenede Stater, 85718
        • Pima Heart and Vascular
    • California
      • Orange, California, Forenede Stater, 92868
        • St. Joseph Hospital
    • Connecticut
      • Darien, Connecticut, Forenede Stater, 06820
        • Vascular Care Connecticut
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Nephrology Associates
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32256
        • First Coast Cardiovascular Institute
      • Miami, Florida, Forenede Stater, 33169
        • Open Access Miami, LLC
      • Oscala, Florida, Forenede Stater, 34471
        • Leesburg Vascular Access Center & Discovery Medical Research
      • Pensacola, Florida, Forenede Stater, 32504
        • Coastal Vascular and Interventional
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Medical Center
      • Chicago, Illinois, Forenede Stater, 60559
        • Chicago Access Center
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Hospital and Methodist Hospital
    • Kentucky
      • Ashland, Kentucky, Forenede Stater, 41101
        • King's Daughters Medical Center
    • Massachusetts
      • West Roxbury, Massachusetts, Forenede Stater, 02130
        • Brigham and Women's Faulkner Hospital
    • Michigan
      • Flint, Michigan, Forenede Stater, 48507
        • Michigan Vascular Access Center
    • New Jersey
      • Vineland, New Jersey, Forenede Stater, 80360
        • Vascular Institute of Atlantic Medical Imaging
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • UNC Health
      • Charlotte, North Carolina, Forenede Stater, 28202
        • Charlotte Radiology
      • Raleigh, North Carolina, Forenede Stater, 27607
        • NC Heart and Vascular Research
      • Raleigh, North Carolina, Forenede Stater, 27610
        • North Carolina Nephrology Raleigh Access
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University Pittsburg Medical Center
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02906
        • Providence Access Center
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health System Upstate
    • Texas
      • Dallas, Texas, Forenede Stater, 75235
        • Renal Disease Research Institute
      • Dallas, Texas, Forenede Stater, 75226
        • Soltero Cardiovascular Research Center
      • Fort Worth, Texas, Forenede Stater, 76104
        • PPG Health PA, DBA-Tarrant Vascular
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
      • Houston, Texas, Forenede Stater, 77008
        • Global Kidney Associates
      • Katy, Texas, Forenede Stater, 77494
        • University of Texas Health - Memorial Hermann Katy Hospital
      • Pasadena, Texas, Forenede Stater, 77504
        • CDVA
      • Plano, Texas, Forenede Stater, 75093
        • Dallas Nephrology Associates
    • Virginia
      • Virginia Beach, Virginia, Forenede Stater, 23507
        • Sentara Vascular Specialists

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

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Emnet giver skriftligt informeret samtykke
  • Forsøgspersonen er mand eller kvinde, med en alder ≥ 18 år på tilmeldingsdatoen.
  • Forsøgspersonen er villig til at gennemgå alle opfølgende vurderinger.
  • Forsøgspersonen har en forventet levetid på ≥ 12 måneder.
  • Personen gennemgår kronisk hæmodialyse.
  • Forsøgspersonen har enten en moden AVF eller AVG i armen.
  • Mållæsioner involverer en de novo stenotisk eller ikke-stentet restenotisk læsion.
  • Mållæsionen har ≥50 % stenose.
  • Mållæsion(er) referencekardiameter er mellem 5,0 mm og 14,0 mm

Ekskluderingskriterier:

  • Forsøgspersonen har en kendt eller mistænkt infektion i hæmodialyse-adgangsstedet, systemisk infektion og/eller septikæmi.
  • Forsøgspersonen har en apopleksidiagnose inden for 3 måneder før indskrivning.
  • Forsøgspersonen har en historie med ustabil angina eller myokardieinfarkt inden for 60 dage før indskrivning.
  • Forsøgspersonen er gravid, ammer eller har til hensigt at blive gravid inden for det næste år.
  • Mållæsion er lokaliseret inden i en stent/stentgraft.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: AVF Perifer undersøgelses behandlingsgruppe
Forsøgspersoner randomiseret til behandling med WRAPSODY endovaskulær stentgraft
Enhed: Merit WRAPSODY Endovaskulær stentgraft
Mållæsion behandlet med stentgraftplacering
Andet: AVF Perifer kontrolgruppe
Forsøgspersoner randomiseret til behandling med standard perkutan transluminal angioplastik (PTA)
Enhed: PTA
Mållæsion behandlet med standard perkutan transluminal angioplastik (PTA)
Eksperimentel: AVG anastomose
Alle forsøgspersoner i denne enkeltarmskohorte vil modtage behandling med WRAPSODY Endovaskulær Stentgraft
Enhed: Merit WRAPSODY Endovaskulær stentgraft
Mållæsion behandlet med stentgraftplacering

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjects Without Any Localized or Systemic Safety Events (Primary Safety Endpoint)
Tidsramme: 30 days
Percentage of subjects without any localized or systemic safety events through 30 days post-index procedure that affect the access or venous outflow circuit and resulted in reintervention, hospitalization, or death (not including stenosis or thrombosis). Endovascular procedures performed to treat safety events after the index study procedure will be considered surgeries.
30 days
Subjects With Target Lesion Primary Patency (TLPP) (Primary Effectiveness Endpoint:)
Tidsramme: 6 months
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 6 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjects With Target Lesion Primary Patency
Tidsramme: 12 months
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 12 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
12 months
Subjects With Target Lesion Primary Patency
Tidsramme: 24 months
Percentage of subjects with Target Lesion Primary Patency (TLPP) at 24 Months. TLPP is defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or target lesion thrombosis measured through 6 months post-procedure, which is the time interval of uninterrupted patency after study procedure to the next intervention performed on the target lesion or uncorrectable target lesion occlusion.
24 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
Tidsramme: 6 months

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 6 months.

aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
6 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
Tidsramme: 12 months

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 12 months.

aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
12 months
Subjects With Assisted Target Lesion Primary Patency (aTLPP)
Tidsramme: 24 months

Kaplan Meier Estimate Percent Probability of Assisted Target Lesion Primary Patency at 24 months.

aTLPP was defined as time to loss of Assisted Primary Patency of the target lesion, which is the time from post-procedure until uncorrectable target lesion occlusion. Participants who did not experience loss of aTLPP were censored at the time of last available follow-up.
24 months
Subjects With Access Circuit Primary Patency (ACPP)
Tidsramme: 6 months
6 months
Subjects With Access Circuit Primary Patency (ACPP)
Tidsramme: 12 months
12 months
Subjects With Access Circuit Primary Patency (ACPP)
Tidsramme: 24 months
24 months
Subjects With Post-Procedure Secondary Patency
Tidsramme: 6 months

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 6 months.

Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
6 months
Subjects With Post-Procedure Secondary Patency
Tidsramme: 12 months

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 12 months.

Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
12 months
Subjects With Post-Procedure Secondary Patency
Tidsramme: 24 months

Kaplan Meier Estimate Percent Probability of Post-Procedure Secondary Patency at 24 months.

Post-Procedure Secondary Patency was defined as the interval post-procedure until access circuit abandonment. Participants who did not experience loss of Post-Procedure Secondary Patency were censored at the time of last available follow-up.
24 months
Rates of Procedure-related Adverse Events Involving the Access Circuit
Tidsramme: Index procedure
Rates of procedure-related adverse events involving the access circuit at index procedure
Index procedure
Rates of Device-related Adverse Events Involving the Access Circuit
Tidsramme: Index procedure
Rates of device-related adverse events involving the access circuit at index procedure
Index procedure
Rates of Procedure-related Adverse Events Involving the Access Circuit
Tidsramme: 30 days
Rates of procedure-related adverse events involving the access circuit at 30 days
30 days
Rates of Device-related Adverse Events Involving the Access Circuit
Tidsramme: 30 days
Rates of device-related adverse events involving the access circuit at 30 days
30 days
Rates of Procedure-related Adverse Events Involving the Access Circuit
Tidsramme: 6 months
Rates of procedure-related adverse events involving the access circuit at 6 months
6 months
Rates of Device-related Adverse Events Involving the Access Circuit
Tidsramme: 6 months
Rates of device-related adverse events involving the access circuit at 6 months
6 months
Rates of Procedure-related Adverse Events Involving the Access Circuit
Tidsramme: 12 Months
Rates of procedure-related adverse events involving the access circuit at 12 months
12 Months
Rates of Device-related Adverse Events Involving the Access Circuit
Tidsramme: 12 Months
Rates of device-related adverse events involving the access circuit at 12 months
12 Months
Rates of Procedure-related Adverse Events Involving the Access Circuit
Tidsramme: 24 Months
Rates of procedure-related adverse events involving the access circuit at 24 months
24 Months
Rates of Device-related Adverse Events Involving the Access Circuit
Tidsramme: 24 Months
Rates of device-related adverse events involving the access circuit at 24 months
24 Months

Samarbejdspartnere og efterforskere

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

Sponsor

Merit Medical Systems, Inc.

Efterforskere

  • Ledende efterforsker: Robert Jones, MD, The Queen Elizabeth Hospital
  • Ledende efterforsker: Mahmood K Razavi, MD, St. Joseph's Hospital, Orange, CA

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)

9. marts 2021

Primær færdiggørelse (Faktiske)

22. februar 2024

Studieafslutning (Faktiske)

25. juli 2025

Datoer for studieregistrering

Først indsendt

1. september 2020

Først indsendt, der opfyldte QC-kriterier

1. september 2020

Først opslået (Faktiske)

7. september 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CVO-P3-20-01

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Kliniske forsøg med Venøs stenose

Kliniske forsøg med Merit WRAPSODY Endovaskulær stentgraft

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mauritius

Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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