Clinical trial NCT05378347: Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Official title: Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)
Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
Keywords: EVAR, AAA
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 550
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sac Regression
timeFrame: 12 months
Secondary outcomes:
measure: Aneurysm sac change by diameter as a continuous variable
timeFrame: 12 months and annually to 5 years
measure: Aneurysm sac change by volume incidence rate
timeFrame: 12 months and annually to 5 years
measure: Type II endoleak incidence rate
timeFrame: 30 days, 12 months and annually to 5 years
measure: Type I endoleak incidence rate
timeFrame: 30 days,12 months and annually to 5 years
measure: Secondary intervention incidence rate
timeFrame: 30 days, 12 months and annually to 5 years
measure: All cause mortality incidence rate
timeFrame: 30 days, 12 months and annually to 5 years
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco UCSF Medical Center
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: New Haven
country: United States
facility: Yale Center for Clinical Investigation
state: Connecticut
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital Forsyth
state: Georgia
city: Skokie
country: United States
facility: Northshore University Health System
state: Illinois
city: Wichita
country: United States
facility: Ascension Via Christi Saint Francis
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: Northwell Health Lenox Hill Hospital
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Novant Health Forsyth Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals, Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Memphis
country: United States
facility: Cardiovascular Surgery Clinic
state: Tennessee
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille Hopital de la Timone
state: Marseille Cedex
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lyon
country: France
facility: Hospices Civils de Lyon-CHU Lyon
city: Strasbourg
country: France
facility: Hopital de Hautepierre - CHU de Strasbourg
city: Augsburg
country: Germany
facility: University Hospital Augsburg
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Essen
country: Germany
facility: Elisabeth Hospital Essen
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Munich
country: Germany
facility: University Hospital rechts der Isar of the Technical University Munich
city: Münster
country: Germany
facility: St. Franziskus Hospital Munster
city: Larisa
country: Greece
facility: University Hospital of Larisa
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Torino
country: Italy
facility: AOU Citta della Salute e della Scienza di Torino
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Asahikawa City
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Chuo Ku
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: The Netherlands
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Center
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Palma
country: Spain
facility: Hospital Universitario Son Espases
state: Mallorca
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust - John Radcliffe Hospital
state: Oxfordshire
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: Beth Israel Deaconess Medical Center, United States
name: Marc Schermerhorn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus University Medical Center, Netherlands
name: Hence Verhagen, MD
role: PRINCIPAL_INVESTIGATOR
References: