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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Interventionnelle600 participants recherchés68 sites12 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

Résumé

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.

Affections

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

Éligibilité

SexeTous
Âges20 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhaseSans objet
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuSINGLE (1)
Recrutement600 participants recherchés

Promoteur et collaborateurs

  • Medtronic Cardiovascular Promoteur

Groupes et interventions

  • 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.

Interventions

  • Dispositif Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

    EVAR treatment with Excluder / Excluder Conformable Stent Graft System

  • Dispositif Medtronic Endurant II or Endurant IIs Stent Graft System

    EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

Critères de jugement

  1. Critère de jugement 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.

    Délai 12 months

  2. Critère de jugement secondaire

    Aneurysm sac change by diameter as a continuous variable

    Délai 12 months and annually to 5 years

  3. Critère de jugement secondaire

    Aneurysm sac change by volume incidence rate

    Délai 12 months and annually to 5 years

  4. Critère de jugement secondaire

    Type II endoleak incidence rate

    Délai 30 days, 12 months and annually to 5 years

  5. Critère de jugement secondaire

    Type I endoleak incidence rate

    Délai 30 days,12 months and annually to 5 years

  6. Critère de jugement secondaire

    Secondary intervention incidence rate

    Délai 30 days, 12 months and annually to 5 years

  7. Critère de jugement secondaire

    All cause mortality incidence rate

    Délai 30 days, 12 months and annually to 5 years

Dates

Date de début5 janvier 2023 (réelle)
Achèvement principal1 mai 2027 (estimée)
Achèvement1 mai 2031 (estimée)
Première publication18 mai 2022 (réelle)
Dernière mise à jour6 juillet 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuillet 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

63 sites sont en recrutement

Finland

ÉtablissementVilleÉtat ou régionStatut
Helsinki University HospitalHelsinkiEn recrutement
Kuopio University HospitalKuopioEn recrutement

France

ÉtablissementVilleÉtat ou régionStatut
CHU Clermont-FerrandClermont-FerrandEn recrutement
Hospices Civils de Lyon-CHU LyonLyonRetiré
Assistance Publique - Hopitaux de Marseille Hopital de la TimoneMarseilleMarseille CedexEn recrutement
Hopital de Hautepierre - CHU de StrasbourgStrasbourgEn recrutement

Germany

ÉtablissementVilleÉtat ou régionStatut
University Hospital AugsburgAugsburgEn recrutement
University Hospital CologneCologneEn recrutement
Elisabeth Hospital EssenEssenEn recrutement
Universitatsklinikum FrankfurtFrankfurtEn recrutement
University Hospital LeipzigLeipzigEn recrutement
University Hospital rechts der Isar of the Technical University MunichMunichEn recrutement
St. Franziskus Hospital MunsterMünsterEn recrutement

Greece

ÉtablissementVilleÉtat ou régionStatut
University Hospital of LarisaLarissaEn recrutement

Italy

ÉtablissementVilleÉtat ou régionStatut
Fondazione IRCCS Ca' Granda - Ospendale Maggiore PoliclinicoMilanEn recrutement
Azienda Ospedaliera Universitaria Federico IINaplesEn recrutement
AOU Citta della Salute e della Scienza di TorinoTorinoEn recrutement

Japan

ÉtablissementVilleÉtat ou régionStatut
Asahikawa Medical University HospitalAsahikawaHokkaidoEn recrutement
Niigata University Medical and Dental HospitalChuo KuNiigataEn recrutement
Hamamatsu University HospitalHamamatsuShizuokaEn recrutement
Nagoya University HospitalNagoyaAichi-kenEn recrutement
Osaka Keisatsu HospitalOsakaEn recrutement
Keio University HospitalShinjuku-KuTokyoEn recrutement

Netherlands

ÉtablissementVilleÉtat ou régionStatut
Amsterdam University Medical CenterAmsterdamEn recrutement
Rijnstate HospitalArnhemThe NetherlandsEn recrutement
Catharina ZiekenhuisEindhovenEn recrutement
Erasmus Medisch CentrumRotterdamEn recrutement

Spain

ÉtablissementVilleÉtat ou régionStatut
Hospital Universitario Son EspasesPalmaMallorcaEn recrutement

Switzerland

ÉtablissementVilleÉtat ou régionStatut
Centre Hospitalier Universitaire VaudoisLausanneEn recrutement
Luzerner KantonsspitalLucerneEn recrutement

Taiwan

ÉtablissementVilleÉtat ou régionStatut
China Medical University HospitalTaichungEn recrutement
Chi Mei Medical CenterTainanEn recrutement
National Taiwan University HospitalTaipeiEn recrutement
Taipei Veterans General HospitalTaipeiEn recrutement

United Kingdom

ÉtablissementVilleÉtat ou régionStatut
Royal Infirmary of EdinburghEdinburghEn recrutement
Oxford University Hospitals NHS Trust - John Radcliffe HospitalOxfordOxfordshireEn recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Albany Medical CollegeAlbanyNew YorkRetiré
Northside Hospital ForsythAtlantaGeorgiaEn recrutement
VA Maryland Health Care SystemBaltimoreMarylandEn recrutement
Beth Israel Deaconess Medical CenterBostonMassachusettsEn recrutement
University of Virginia Health SystemCharlottesvilleVirginiaEn recrutement
University Hospitals, Cleveland Medical CenterClevelandOhioEn recrutement
Denver Health Medical CenterDenverColoradoEn recrutement
Prisma HealthGreenvilleSouth CarolinaRetiré
University of Texas Health Science Center at HoustonHoustonTexasEn recrutement
Mayo Clinic JacksonvilleJacksonvilleFloridaEn recrutement
University of KentuckyLexingtonKentuckyEn recrutement
Loma Linda University Medical CenterLoma LindaCaliforniaEn recrutement
Cardiovascular Surgery ClinicMemphisTennesseeRetiré
Minneapolis Heart Institute FoundationMinneapolisMinnesotaEn recrutement

18 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

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