Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Abdominal Aortic Aneurysm Clinical Trial

— ADVANCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378347
• Other study ID #: MDT21033
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: May 2029

Study information

• Verified date: May 2024
• Source: Medtronic Cardiovascular
• Contact: ADVANCE Trial Clinical Study Team
• Phone: 763-514-4000
• Email: rs.advancestudy[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. An estimate of 550 subjects (minimum 500) are enrolled at up to 100 sites globally, with the potential to extend enrollment up to 900 subjects based on predictive probability analysis to adequately achieve either non-inferiority or superiority for the primary endpoint. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: May 2029
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subject and the treating physician agree that the subject will return for all required followup 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)
• 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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	Hospices Civils de Lyon-CHU Lyon	Lyon
France	Assistance Publique - Hopitaux de Marseille Hopital de la Timone	Marseille	Marseille Cedex
France	Hopital de Hautepierre - CHU de Strasbourg	Strasbourg
Germany	University Hospital Augsburg	Augsburg
Germany	University Hospital Cologne	Cologne
Germany	Universitatsklinikum Frankfurt	Frankfurt
Germany	St. Franziskus Hospital Munster	Münster
Italy	Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico	Milano
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli
Italy	AOU Citta della Salute e della Scienza di Torino	Torino
Japan	Asahikawa Medical University Hospital	Asahikawa City	Hokkaido
Japan	Niigata University Medical and Dental Hospital	Chuo Ku	Niigata
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Keio University Hospital	Shinjuku-Ku	Tokyo
Netherlands	Rijnstate Hospital	Arnhem	The Netherlands
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Erasmus Medisch Centrum	Rotterdam
Spain	Hospital Universitario Son Espases	Palma	Mallorca
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Switzerland	Luzerner Kantonsspital	Luzern
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chi Mei Medical Center	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Oxford University Hospitals NHS Trust - John Radcliffe Hospital	Oxford	Oxfordshire
United States	Albany Medical College	Albany	New York
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University Hospitals, Cleveland Medical Center	Cleveland	Ohio
United States	Denver Health Medical Center	Denver	Colorado
United States	Prisma Health	Greenville	South Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	University of Kentucky	Lexington	Kentucky
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Cardiovascular Surgery Clinic	Memphis	Tennessee
United States	Yale Center for Clinical Investigation	New Haven	Connecticut
United States	Northwell Health Lenox Hill Hospital	New York	New York
United States	University of California Irvine Medical Center	Orange	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Maine Medical Center	Portland	Maine
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of California Davis Medical Center	Sacramento	California
United States	University of California San Francisco UCSF Medical Center	San Francisco	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Westchester Medical Center	Valhalla	New York
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Ascension Via Christi Saint Francis	Wichita	Kansas
United States	Novant Health Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Finland,  France,  Germany,  Italy,  Japan,  Netherlands,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Aneurysm sac change by diameter as a continuous variable		12 months and annually to 5 years
Secondary	Aneurysm sac change by volume incidence rate		12 months and annually to 5 years
Secondary	Type II endoleak incidence rate		30 days, 12 months and annually to 5 years
Secondary	Type I endoleak incidence rate		30 days,12 months and annually to 5 years
Secondary	Secondary intervention incidence rate		30 days, 12 months and annually to 5 years
Secondary	All cause mortality incidence rate		30 days, 12 months and annually to 5 years