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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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…

Interventionell600 Teilnehmende gesucht68 Studienzentren12 Länder

Kategorien

Herz-Kreislauf100%

In 1 Register registriert

ClinicalTrials.govNCT05378347Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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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.

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

Zusammenfassung

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.

Erkrankungen

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

Eignung

Eignung
Geschlecht	Alle
Alter	20 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

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

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Nicht zutreffend
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	SINGLE (1)
Teilnahme	600 Teilnehmende gesucht

Sponsor und Mitwirkende

Medtronic Cardiovascular Sponsor

Studienarme und Interventionen

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.

Interventionen

Medizinprodukt Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis
EVAR treatment with Excluder / Excluder Conformable Stent Graft System
Medizinprodukt Medtronic Endurant II or Endurant IIs Stent Graft System
EVAR treatment with Medtronic Endurant II/IIs Stent Graft System

Endpunkte

Primärer Endpunkt
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.
Zeitrahmen 12 months
Sekundärer Endpunkt
Aneurysm sac change by diameter as a continuous variable
Zeitrahmen 12 months and annually to 5 years
Sekundärer Endpunkt
Aneurysm sac change by volume incidence rate
Zeitrahmen 12 months and annually to 5 years
Sekundärer Endpunkt
Type II endoleak incidence rate
Zeitrahmen 30 days, 12 months and annually to 5 years
Sekundärer Endpunkt
Type I endoleak incidence rate
Zeitrahmen 30 days,12 months and annually to 5 years
Sekundärer Endpunkt
Secondary intervention incidence rate
Zeitrahmen 30 days, 12 months and annually to 5 years
Sekundärer Endpunkt
All cause mortality incidence rate
Zeitrahmen 30 days, 12 months and annually to 5 years

Daten

Daten
Startdatum	5. Januar 2023 (tatsächlich)
Primärer Abschluss	1. Mai 2027 (geschätzt)
Abschluss	1. Mai 2031 (geschätzt)
Erstveröffentlichung	18. Mai 2022 (tatsächlich)
Zuletzt aktualisiert	6. Juli 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juli 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

63 Studienzentren rekrutieren

Finland

Finland
Einrichtung	Stadt	Bundesland oder Region	Status
Helsinki University Hospital	Helsinki		Rekrutiert
Kuopio University Hospital	Kuopio		Rekrutiert

France

France
Einrichtung	Stadt	Bundesland oder Region	Status
CHU Clermont-Ferrand	Clermont-Ferrand		Rekrutiert
Hospices Civils de Lyon-CHU Lyon	Lyon		Zurückgezogen
Assistance Publique - Hopitaux de Marseille Hopital de la Timone	Marseille	Marseille Cedex	Rekrutiert
Hopital de Hautepierre - CHU de Strasbourg	Strasbourg		Rekrutiert

Germany

Germany
Einrichtung	Stadt	Status
University Hospital Augsburg	Augsburg	Rekrutiert
University Hospital Cologne	Cologne	Rekrutiert
Elisabeth Hospital Essen	Essen	Rekrutiert
Universitatsklinikum Frankfurt	Frankfurt	Rekrutiert
University Hospital Leipzig	Leipzig	Rekrutiert
University Hospital rechts der Isar of the Technical University Munich	Munich	Rekrutiert
St. Franziskus Hospital Munster	Münster	Rekrutiert

Greece

Greece
Einrichtung	Stadt	Bundesland oder Region	Status
University Hospital of Larisa	Larissa		Rekrutiert

Italy

Italy
Einrichtung	Stadt	Status
Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico	Milan	Rekrutiert
Azienda Ospedaliera Universitaria Federico II	Naples	Rekrutiert
AOU Citta della Salute e della Scienza di Torino	Torino	Rekrutiert

Japan

Japan
Einrichtung	Stadt	Bundesland oder Region	Status
Asahikawa Medical University Hospital	Asahikawa	Hokkaido	Rekrutiert
Niigata University Medical and Dental Hospital	Chuo Ku	Niigata	Rekrutiert
Hamamatsu University Hospital	Hamamatsu	Shizuoka	Rekrutiert
Nagoya University Hospital	Nagoya	Aichi-ken	Rekrutiert
Osaka Keisatsu Hospital	Osaka		Rekrutiert
Keio University Hospital	Shinjuku-Ku	Tokyo	Rekrutiert

Netherlands

Netherlands
Einrichtung	Stadt	Bundesland oder Region	Status
Amsterdam University Medical Center	Amsterdam		Rekrutiert
Rijnstate Hospital	Arnhem	The Netherlands	Rekrutiert
Catharina Ziekenhuis	Eindhoven		Rekrutiert
Erasmus Medisch Centrum	Rotterdam		Rekrutiert

Spain

Spain
Einrichtung	Stadt	Bundesland oder Region	Status
Hospital Universitario Son Espases	Palma	Mallorca	Rekrutiert

Switzerland

Switzerland
Einrichtung	Stadt	Bundesland oder Region	Status
Centre Hospitalier Universitaire Vaudois	Lausanne		Rekrutiert
Luzerner Kantonsspital	Lucerne		Rekrutiert

Taiwan

Taiwan
Einrichtung	Stadt	Status
China Medical University Hospital	Taichung	Rekrutiert
Chi Mei Medical Center	Tainan	Rekrutiert
National Taiwan University Hospital	Taipei	Rekrutiert
Taipei Veterans General Hospital	Taipei	Rekrutiert

United Kingdom

United Kingdom
Einrichtung	Stadt	Bundesland oder Region	Status
Royal Infirmary of Edinburgh	Edinburgh		Rekrutiert
Oxford University Hospitals NHS Trust - John Radcliffe Hospital	Oxford	Oxfordshire	Rekrutiert

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
Albany Medical College	Albany	New York	Zurückgezogen
Northside Hospital Forsyth	Atlanta	Georgia	Rekrutiert
VA Maryland Health Care System	Baltimore	Maryland	Rekrutiert
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Rekrutiert
University of Virginia Health System	Charlottesville	Virginia	Rekrutiert
University Hospitals, Cleveland Medical Center	Cleveland	Ohio	Rekrutiert
Denver Health Medical Center	Denver	Colorado	Rekrutiert
Prisma Health	Greenville	South Carolina	Zurückgezogen
University of Texas Health Science Center at Houston	Houston	Texas	Rekrutiert
Mayo Clinic Jacksonville	Jacksonville	Florida	Rekrutiert
University of Kentucky	Lexington	Kentucky	Rekrutiert
Loma Linda University Medical Center	Loma Linda	California	Rekrutiert
Cardiovascular Surgery Clinic	Memphis	Tennessee	Zurückgezogen
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	Rekrutiert

18 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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