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NCT05378347ClinicalTrials.gov

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression

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En resumen

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging…

De intervención600 participantes buscados68 centros12 países

Categorías

Cardiovascular100%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2022-05-18; recorded start 2023-01-05
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 19 other studies in this databaseCounted from the lead sponsor named in the record (Medtronic Cardiovascular)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 3 conditions.
  • Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourMODERATE

A moderately rigorous design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding7/20

    Single-blind

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 68 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 600 participants (target), run at 68 sites, across 12 countries.

How this score is built
  • Enrolment27/40

    600 participants (target)

  • Site count21/25

    68 sites

  • Country count12/15

    12 countries

  • Planned duration10/10

    Planned over about 101 months

  • Sponsor scale4/10

    Medtronic Cardiovascular has led 19 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

This is a post-market, prospective, interventional, global, multi-center, randomized, dual-arm clinical trial. The primary objective of this trial is to evaluate sac regression outcomes of the Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis in standard EVAR subjects. Subjects are randomized on a 1:1 basis to receive EVAR with either a Medtronic Endurant II/IIs Stent Graft Systems or Gore Excluder / Excluder Conformable AAA Endoprosthesis. Data is collected pre- and post-procedure at discharge, at 30 days, and once a year until the 5-year follow-up is completed. Approximately 600 subjects are planned to be enrolled at up to 100 sites globally. Product Names: * Medtronic Endurant II/IIs Stent Graft System * Gore Excluder and/or Gore Excluder Conformable AAA Endoprosthesis Imaging is collected for all follow-up time points and are evaluated by a core lab for the key primary and secondary objectives.

Afecciones

  • Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
  • Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
  • Abdominal Aortic Aneurysm

Elegibilidad

SexoTodos
Edades20 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Subject and the treating physician agree that the subject will return for all required follow up visits * Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee/Institutional Review Board * Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda. * Subject's AAA anatomy is appropriate for both Medtronic Endurant II/IIs Stent Graft System and Gore Excluder/Excluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region. Exclusion Criteria: * Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial * Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator * Subject has an aneurysm that is: 1. Suprarenal/pararenal/juxtarenal 2. Isolated ilio-femoral 3. Mycotic 4. Inflammatory 5. Pseudoaneurysm 6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries 7. Ruptured 8. Symptomatic AAA * Subject has significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and / or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck. * Subject requires emergent aneurysm treatment, for example, trauma or rupture * Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome * Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease * Planned use of aorto-uni-iliac (AUI) main body device * Any planned additional device (apart from the main body, limb stent graft and extensions per assigned treatment per randomization) during index or staged procedure, e.g., endostaple or anchor, Iliac branch endoprosthesis, embolization, etc. * Planned coverage of the internal iliac artery/arteries * Subject has an estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2 or subject is on dialysis * Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion * Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion * Subject is of childbearing potential in whom pregnancy cannot be excluded * Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment * Subject belongs to a vulnerable population per investigator's judgment * Subject has an active COVID-19 infection or relevant history of COVID- 19

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseNo aplicable
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoSINGLE (1)
Inscripción600 participantes buscados

Patrocinador y colaboradores

  • Medtronic Cardiovascular Patrocinador

Grupos e intervenciones

  • Medtronic Endurant II/IIsEXPERIMENTAL

    Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.

  • Gore Excluder / Excluder ConformableEXPERIMENTAL

    Subjects are randomized on a 1:1 basis to receive an EVAR procedure with either a Medtronic Endurant II/IIs endoprothesis or Gore's Excluder / Excluder Conformable.

Intervenciones

  • Dispositivo Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

    EVAR treatment with Excluder / Excluder Conformable Stent Graft System

  • Dispositivo Medtronic Endurant II or Endurant IIs Stent Graft System

    EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

Variables de resultado

  1. Variable de resultado principal

    Sac Regression

    Proportion of patients with sac regression at 1 year, defined in accordance with SVS guidelines as the reduction in maximum diameter by \>= 5 mm when compared to the first CT imaging study obtained within 90 days after index procedure.

    Plazo 12 months

  2. Variable de resultado secundaria

    Aneurysm sac change by diameter as a continuous variable

    Plazo 12 months and annually to 5 years

  3. Variable de resultado secundaria

    Aneurysm sac change by volume incidence rate

    Plazo 12 months and annually to 5 years

  4. Variable de resultado secundaria

    Type II endoleak incidence rate

    Plazo 30 days, 12 months and annually to 5 years

  5. Variable de resultado secundaria

    Type I endoleak incidence rate

    Plazo 30 days,12 months and annually to 5 years

  6. Variable de resultado secundaria

    Secondary intervention incidence rate

    Plazo 30 days, 12 months and annually to 5 years

  7. Variable de resultado secundaria

    All cause mortality incidence rate

    Plazo 30 days, 12 months and annually to 5 years

Fechas

Fecha de inicio5 de enero de 2023 (real)
Finalización principal1 de mayo de 2027 (estimada)
Finalización1 de mayo de 2031 (estimada)
Primera publicación18 de mayo de 2022 (real)
Última actualización6 de julio de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezjulio de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

63 centros están en reclutamiento

Finland

CentroCiudadEstado o regiónEstado
Helsinki University HospitalHelsinkiEn reclutamiento
Kuopio University HospitalKuopioEn reclutamiento

France

CentroCiudadEstado o regiónEstado
CHU Clermont-FerrandClermont-FerrandEn reclutamiento
Hospices Civils de Lyon-CHU LyonLyonRetirado
Assistance Publique - Hopitaux de Marseille Hopital de la TimoneMarseilleMarseille CedexEn reclutamiento
Hopital de Hautepierre - CHU de StrasbourgStrasbourgEn reclutamiento

Germany

CentroCiudadEstado o regiónEstado
University Hospital AugsburgAugsburgEn reclutamiento
University Hospital CologneCologneEn reclutamiento
Elisabeth Hospital EssenEssenEn reclutamiento
Universitatsklinikum FrankfurtFrankfurtEn reclutamiento
University Hospital LeipzigLeipzigEn reclutamiento
University Hospital rechts der Isar of the Technical University MunichMunichEn reclutamiento
St. Franziskus Hospital MunsterMünsterEn reclutamiento

Greece

CentroCiudadEstado o regiónEstado
University Hospital of LarisaLarissaEn reclutamiento

Italy

CentroCiudadEstado o regiónEstado
Fondazione IRCCS Ca' Granda - Ospendale Maggiore PoliclinicoMilanEn reclutamiento
Azienda Ospedaliera Universitaria Federico IINaplesEn reclutamiento
AOU Citta della Salute e della Scienza di TorinoTorinoEn reclutamiento

Japan

CentroCiudadEstado o regiónEstado
Asahikawa Medical University HospitalAsahikawaHokkaidoEn reclutamiento
Niigata University Medical and Dental HospitalChuo KuNiigataEn reclutamiento
Hamamatsu University HospitalHamamatsuShizuokaEn reclutamiento
Nagoya University HospitalNagoyaAichi-kenEn reclutamiento
Osaka Keisatsu HospitalOsakaEn reclutamiento
Keio University HospitalShinjuku-KuTokyoEn reclutamiento

Netherlands

CentroCiudadEstado o regiónEstado
Amsterdam University Medical CenterAmsterdamEn reclutamiento
Rijnstate HospitalArnhemThe NetherlandsEn reclutamiento
Catharina ZiekenhuisEindhovenEn reclutamiento
Erasmus Medisch CentrumRotterdamEn reclutamiento

Spain

CentroCiudadEstado o regiónEstado
Hospital Universitario Son EspasesPalmaMallorcaEn reclutamiento

Switzerland

CentroCiudadEstado o regiónEstado
Centre Hospitalier Universitaire VaudoisLausanneEn reclutamiento
Luzerner KantonsspitalLucerneEn reclutamiento

Taiwan

CentroCiudadEstado o regiónEstado
China Medical University HospitalTaichungEn reclutamiento
Chi Mei Medical CenterTainanEn reclutamiento
National Taiwan University HospitalTaipeiEn reclutamiento
Taipei Veterans General HospitalTaipeiEn reclutamiento

United Kingdom

CentroCiudadEstado o regiónEstado
Royal Infirmary of EdinburghEdinburghEn reclutamiento
Oxford University Hospitals NHS Trust - John Radcliffe HospitalOxfordOxfordshireEn reclutamiento

United States

CentroCiudadEstado o regiónEstado
Albany Medical CollegeAlbanyNew YorkRetirado
Northside Hospital ForsythAtlantaGeorgiaEn reclutamiento
VA Maryland Health Care SystemBaltimoreMarylandEn reclutamiento
Beth Israel Deaconess Medical CenterBostonMassachusettsEn reclutamiento
University of Virginia Health SystemCharlottesvilleVirginiaEn reclutamiento
University Hospitals, Cleveland Medical CenterClevelandOhioEn reclutamiento
Denver Health Medical CenterDenverColoradoEn reclutamiento
Prisma HealthGreenvilleSouth CarolinaRetirado
University of Texas Health Science Center at HoustonHoustonTexasEn reclutamiento
Mayo Clinic JacksonvilleJacksonvilleFloridaEn reclutamiento
University of KentuckyLexingtonKentuckyEn reclutamiento
Loma Linda University Medical CenterLoma LindaCaliforniaEn reclutamiento
Cardiovascular Surgery ClinicMemphisTennesseeRetirado
Minneapolis Heart Institute FoundationMinneapolisMinnesotaEn reclutamiento

En el registro figuran 18 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.

Registro: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05378347