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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
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In breve

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…

Interventistico600 partecipanti ricercati68 centri12 paesi

Categorie

Cardiovascolare100%

Registrato in 1 registro

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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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.

Patologie

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

Idoneità

SessoTutti
Età20 Years – Nessun massimo
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Tipo di studioInterventistico
FaseNon applicabile
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoSINGLE (1)
Arruolamento600 partecipanti ricercati

Sponsor e collaboratori

  • Medtronic Cardiovascular Sponsor

Bracci e interventi

  • 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.

Interventi

  • 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

Esiti misurati

  1. Esito primario

    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.

    Orizzonte temporale 12 months

  2. Esito secondario

    Aneurysm sac change by diameter as a continuous variable

    Orizzonte temporale 12 months and annually to 5 years

  3. Esito secondario

    Aneurysm sac change by volume incidence rate

    Orizzonte temporale 12 months and annually to 5 years

  4. Esito secondario

    Type II endoleak incidence rate

    Orizzonte temporale 30 days, 12 months and annually to 5 years

  5. Esito secondario

    Type I endoleak incidence rate

    Orizzonte temporale 30 days,12 months and annually to 5 years

  6. Esito secondario

    Secondary intervention incidence rate

    Orizzonte temporale 30 days, 12 months and annually to 5 years

  7. Esito secondario

    All cause mortality incidence rate

    Orizzonte temporale 30 days, 12 months and annually to 5 years

Date

Data di inizio5 gennaio 2023 (effettiva)
Conclusione primaria1 maggio 2027 (stimata)
Conclusione1 maggio 2031 (stimata)
Prima pubblicazione18 maggio 2022 (effettiva)
Ultimo aggiornamento6 luglio 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltaluglio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

63 centri stanno reclutando

Finland

StrutturaCittàStato o regioneStato
Helsinki University HospitalHelsinkiIn reclutamento
Kuopio University HospitalKuopioIn reclutamento

France

StrutturaCittàStato o regioneStato
CHU Clermont-FerrandClermont-FerrandIn reclutamento
Hospices Civils de Lyon-CHU LyonLyonRitirato
Assistance Publique - Hopitaux de Marseille Hopital de la TimoneMarseilleMarseille CedexIn reclutamento
Hopital de Hautepierre - CHU de StrasbourgStrasbourgIn reclutamento

Germany

StrutturaCittàStato o regioneStato
University Hospital AugsburgAugsburgIn reclutamento
University Hospital CologneCologneIn reclutamento
Elisabeth Hospital EssenEssenIn reclutamento
Universitatsklinikum FrankfurtFrankfurtIn reclutamento
University Hospital LeipzigLeipzigIn reclutamento
University Hospital rechts der Isar of the Technical University MunichMunichIn reclutamento
St. Franziskus Hospital MunsterMünsterIn reclutamento

Greece

StrutturaCittàStato o regioneStato
University Hospital of LarisaLarissaIn reclutamento

Italy

StrutturaCittàStato o regioneStato
Fondazione IRCCS Ca' Granda - Ospendale Maggiore PoliclinicoMilanIn reclutamento
Azienda Ospedaliera Universitaria Federico IINaplesIn reclutamento
AOU Citta della Salute e della Scienza di TorinoTorinoIn reclutamento

Japan

StrutturaCittàStato o regioneStato
Asahikawa Medical University HospitalAsahikawaHokkaidoIn reclutamento
Niigata University Medical and Dental HospitalChuo KuNiigataIn reclutamento
Hamamatsu University HospitalHamamatsuShizuokaIn reclutamento
Nagoya University HospitalNagoyaAichi-kenIn reclutamento
Osaka Keisatsu HospitalOsakaIn reclutamento
Keio University HospitalShinjuku-KuTokyoIn reclutamento

Netherlands

StrutturaCittàStato o regioneStato
Amsterdam University Medical CenterAmsterdamIn reclutamento
Rijnstate HospitalArnhemThe NetherlandsIn reclutamento
Catharina ZiekenhuisEindhovenIn reclutamento
Erasmus Medisch CentrumRotterdamIn reclutamento

Spain

StrutturaCittàStato o regioneStato
Hospital Universitario Son EspasesPalmaMallorcaIn reclutamento

Switzerland

StrutturaCittàStato o regioneStato
Centre Hospitalier Universitaire VaudoisLausanneIn reclutamento
Luzerner KantonsspitalLucerneIn reclutamento

Taiwan

StrutturaCittàStato o regioneStato
China Medical University HospitalTaichungIn reclutamento
Chi Mei Medical CenterTainanIn reclutamento
National Taiwan University HospitalTaipeiIn reclutamento
Taipei Veterans General HospitalTaipeiIn reclutamento

United Kingdom

StrutturaCittàStato o regioneStato
Royal Infirmary of EdinburghEdinburghIn reclutamento
Oxford University Hospitals NHS Trust - John Radcliffe HospitalOxfordOxfordshireIn reclutamento

United States

StrutturaCittàStato o regioneStato
Albany Medical CollegeAlbanyNew YorkRitirato
Northside Hospital ForsythAtlantaGeorgiaIn reclutamento
VA Maryland Health Care SystemBaltimoreMarylandIn reclutamento
Beth Israel Deaconess Medical CenterBostonMassachusettsIn reclutamento
University of Virginia Health SystemCharlottesvilleVirginiaIn reclutamento
University Hospitals, Cleveland Medical CenterClevelandOhioIn reclutamento
Denver Health Medical CenterDenverColoradoIn reclutamento
Prisma HealthGreenvilleSouth CarolinaRitirato
University of Texas Health Science Center at HoustonHoustonTexasIn reclutamento
Mayo Clinic JacksonvilleJacksonvilleFloridaIn reclutamento
University of KentuckyLexingtonKentuckyIn reclutamento
Loma Linda University Medical CenterLoma LindaCaliforniaIn reclutamento
Cardiovascular Surgery ClinicMemphisTennesseeRitirato
Minneapolis Heart Institute FoundationMinneapolisMinnesotaIn reclutamento

Nella scheda del registro sono indicati altri 18 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.

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

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