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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

تدخّليةمطلوب 600 مشارك68 موقعاً12 دولة

الفئات

القلب والأوعية الدموية100%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

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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.

ملخص

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.

الحالات

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

الأهلية

الجنسالجميع
الأعمار20 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةغير منطبق
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةSINGLE (1)
التجنيدمطلوب 600 مشارك

الجهة الراعية والمتعاونون

  • Medtronic Cardiovascular الجهة الراعية

الأذرع والتدخلات

  • 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.

التدخلات

  • جهاز Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

    EVAR treatment with Excluder / Excluder Conformable Stent Graft System

  • جهاز Medtronic Endurant II or Endurant IIs Stent Graft System

    EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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.

    الإطار الزمني 12 months

  2. مقياس النتيجة الثانوي

    Aneurysm sac change by diameter as a continuous variable

    الإطار الزمني 12 months and annually to 5 years

  3. مقياس النتيجة الثانوي

    Aneurysm sac change by volume incidence rate

    الإطار الزمني 12 months and annually to 5 years

  4. مقياس النتيجة الثانوي

    Type II endoleak incidence rate

    الإطار الزمني 30 days, 12 months and annually to 5 years

  5. مقياس النتيجة الثانوي

    Type I endoleak incidence rate

    الإطار الزمني 30 days,12 months and annually to 5 years

  6. مقياس النتيجة الثانوي

    Secondary intervention incidence rate

    الإطار الزمني 30 days, 12 months and annually to 5 years

  7. مقياس النتيجة الثانوي

    All cause mortality incidence rate

    الإطار الزمني 30 days, 12 months and annually to 5 years

التواريخ

تاريخ البدء5 يناير 2023 (فعلي)
الإتمام الأولي1 مايو 2027 (تقديري)
الإتمام1 مايو 2031 (تقديري)
أول نشر18 مايو 2022 (فعلي)
آخر تحديث6 يوليو 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيوليو 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

63 موقعاً قيد التجنيد

Finland

المنشأةالمدينةالولاية أو المنطقةالحالة
Helsinki University HospitalHelsinkiقيد التجنيد
Kuopio University HospitalKuopioقيد التجنيد

France

المنشأةالمدينةالولاية أو المنطقةالحالة
CHU Clermont-FerrandClermont-Ferrandقيد التجنيد
Hospices Civils de Lyon-CHU LyonLyonمسحوب
Assistance Publique - Hopitaux de Marseille Hopital de la TimoneMarseilleMarseille Cedexقيد التجنيد
Hopital de Hautepierre - CHU de StrasbourgStrasbourgقيد التجنيد

Germany

المنشأةالمدينةالولاية أو المنطقةالحالة
University Hospital AugsburgAugsburgقيد التجنيد
University Hospital CologneCologneقيد التجنيد
Elisabeth Hospital EssenEssenقيد التجنيد
Universitatsklinikum FrankfurtFrankfurtقيد التجنيد
University Hospital LeipzigLeipzigقيد التجنيد
University Hospital rechts der Isar of the Technical University MunichMunichقيد التجنيد
St. Franziskus Hospital MunsterMünsterقيد التجنيد

Greece

المنشأةالمدينةالولاية أو المنطقةالحالة
University Hospital of LarisaLarissaقيد التجنيد

Italy

المنشأةالمدينةالولاية أو المنطقةالحالة
Fondazione IRCCS Ca' Granda - Ospendale Maggiore PoliclinicoMilanقيد التجنيد
Azienda Ospedaliera Universitaria Federico IINaplesقيد التجنيد
AOU Citta della Salute e della Scienza di TorinoTorinoقيد التجنيد

Japan

المنشأةالمدينةالولاية أو المنطقةالحالة
Asahikawa Medical University HospitalAsahikawaHokkaidoقيد التجنيد
Niigata University Medical and Dental HospitalChuo KuNiigataقيد التجنيد
Hamamatsu University HospitalHamamatsuShizuokaقيد التجنيد
Nagoya University HospitalNagoyaAichi-kenقيد التجنيد
Osaka Keisatsu HospitalOsakaقيد التجنيد
Keio University HospitalShinjuku-KuTokyoقيد التجنيد

Netherlands

المنشأةالمدينةالولاية أو المنطقةالحالة
Amsterdam University Medical CenterAmsterdamقيد التجنيد
Rijnstate HospitalArnhemThe Netherlandsقيد التجنيد
Catharina ZiekenhuisEindhovenقيد التجنيد
Erasmus Medisch CentrumRotterdamقيد التجنيد

Spain

المنشأةالمدينةالولاية أو المنطقةالحالة
Hospital Universitario Son EspasesPalmaMallorcaقيد التجنيد

Switzerland

المنشأةالمدينةالولاية أو المنطقةالحالة
Centre Hospitalier Universitaire VaudoisLausanneقيد التجنيد
Luzerner KantonsspitalLucerneقيد التجنيد

Taiwan

المنشأةالمدينةالولاية أو المنطقةالحالة
China Medical University HospitalTaichungقيد التجنيد
Chi Mei Medical CenterTainanقيد التجنيد
National Taiwan University HospitalTaipeiقيد التجنيد
Taipei Veterans General HospitalTaipeiقيد التجنيد

United Kingdom

المنشأةالمدينةالولاية أو المنطقةالحالة
Royal Infirmary of EdinburghEdinburghقيد التجنيد
Oxford University Hospitals NHS Trust - John Radcliffe HospitalOxfordOxfordshireقيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Albany Medical CollegeAlbanyNew Yorkمسحوب
Northside Hospital ForsythAtlantaGeorgiaقيد التجنيد
VA Maryland Health Care SystemBaltimoreMarylandقيد التجنيد
Beth Israel Deaconess Medical CenterBostonMassachusettsقيد التجنيد
University of Virginia Health SystemCharlottesvilleVirginiaقيد التجنيد
University Hospitals, Cleveland Medical CenterClevelandOhioقيد التجنيد
Denver Health Medical CenterDenverColoradoقيد التجنيد
Prisma HealthGreenvilleSouth Carolinaمسحوب
University of Texas Health Science Center at HoustonHoustonTexasقيد التجنيد
Mayo Clinic JacksonvilleJacksonvilleFloridaقيد التجنيد
University of KentuckyLexingtonKentuckyقيد التجنيد
Loma Linda University Medical CenterLoma LindaCaliforniaقيد التجنيد
Cardiovascular Surgery ClinicMemphisTennesseeمسحوب
Minneapolis Heart Institute FoundationMinneapolisMinnesotaقيد التجنيد

يُدرَج 18 موقعاً إضافياً في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.

السجل: ClinicalTrials.gov · NCT########

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