Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial (ADVANCE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder); Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)
• Intervention / Treatment: Device: Medtronic Endurant II or Endurant IIs Stent Graft System; Device: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis

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.

• Study Type: Interventional
• Enrollment (Estimated): 550
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ADVANCE Trial Clinical Study Team; Phone Number: 763-514-4000; Email: rs.advancestudy@medtronic.com

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Recruiting
    • Helsinki University Hospital
    • Principal Investigator: Maarit Venermo, MD, PhD
• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • Chu Clermont-Ferrand
    • Principal Investigator: Fabien Thaveau, MD, PhD
  • Lyon, France, 69002
    • Recruiting
    • Hospices Civils de Lyon-CHU Lyon
    • Principal Investigator: Antoine Million, MD, PhD
  • Strasbourg, France, 67200
    • Recruiting
    • Hopital de Hautepierre - CHU de Strasbourg
    • Principal Investigator: Nabil Chakfe, MD, PhD
  • Marseille Cedex
    • Marseille, Marseille Cedex, France, 13385
      • Recruiting
      • Assistance Publique - Hopitaux de Marseille Hopital de la Timone
      • Principal Investigator: Mariangela De Masi, MD
• Germany
  • Augsburg, Germany, 86156
    • Recruiting
    • University Hospital Augsburg
    • Principal Investigator: Alexander Hyhlik-Duerr, MD, PhD
  • Cologne, Germany, 50937
    • Recruiting
    • University Hospital Cologne
    • Principal Investigator: Bernhard Dorweiler, MD, PhD
  • Frankfurt, Germany, 60590
    • Recruiting
    • Universitätsklinikum Frankfurt
    • Principal Investigator: Kyriakos Oikonomou, MD, PhD
  • Münster, Germany, 48145
    • Recruiting
    • St. Franziskus Hospital Munster
    • Principal Investigator: Martin Austermann, MD
• Italy
  • Milano, Italy, 20122
    • Recruiting
    • Fondazione IRCCS Ca' Granda - Ospendale Maggiore Policlinico
    • Principal Investigator: Santi Trimarchi, MD, PhD
  • Napoli, Italy, 80131
    • Recruiting
    • Azienda Ospedaliera Universitaria Federico II
    • Principal Investigator: Umberto Marcello Bracale, MD, PhD
  • Torino, Italy, 10126
    • Recruiting
    • AOU Citta della Salute e della Scienza di Torino
    • Principal Investigator: Fabio Verzini, MD, PhD, FEBVS
• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
      • Recruiting
      • Nagoya University Hospital
      • Principal Investigator: Hirosho Banno, MD, PhD
  • Hokkaido
    • Asahikawa City, Hokkaido, Japan, 078-8510
      • Recruiting
      • Asahikawa Medical University Hospital
      • Principal Investigator: Daiki Uchida, MD, PhD
  • Niigata
    • Chuo Ku, Niigata, Japan, 951-8510
      • Recruiting
      • Niigata University Medical And Dental Hospital
      • Principal Investigator: Takeshi Okamoto, MD, PhD
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3125
      • Recruiting
      • Hamamatsu University Hospital
      • Principal Investigator: Norihiko Shiiya, MD, PhD
  • Tokyo
    • Shinjuku-Ku, Tokyo, Japan, 160-0016
      • Recruiting
      • Keio University Hospital
      • Principal Investigator: Hideyuki Shimizu, MD, PhD
• Netherlands
  • Eindhoven, Netherlands, 5623 EJ
    • Recruiting
    • Catharina Ziekenhuis
    • Principal Investigator: Philippe Cuypers, MD, PhD
  • Rotterdam, Netherlands, 3015 GD
    • Recruiting
    • Erasmus Medisch Centrum
    • Principal Investigator: Hence Verhagen, MD, PhD
  • The Netherlands
    • Arnhem, The Netherlands, Netherlands, 6815 AD
      • Recruiting
      • Rijnstate Hospital
      • Principal Investigator: Michel Reijnen, MD, PhD
• Spain
  • Mallorca
    • Palma, Mallorca, Spain, 07210
      • Recruiting
      • Hospital Universitario Son Espases
      • Principal Investigator: Pascual Lozano-Vilardell, MD
• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • Centre Hospitalier Universitaire Vaudois
    • Principal Investigator: Sebastien Deglise, MD, PhD
  • Luzern, Switzerland, 6000
    • Recruiting
    • Luzerner Kantonsspital
    • Principal Investigator: Maani Hakimi, MD, PhD
• Taiwan
  • Taichung, Taiwan, 404327
    • Recruiting
    • China Medical University Hospital
    • Principal Investigator: You-Cian Lin, MD, PhD
  • Tainan, Taiwan, 710402
    • Recruiting
    • Chi Mei Medical Center
    • Principal Investigator: Nan-Chun Wu, MD
  • Taipei, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
    • Principal Investigator: I-Hui Wu, MD, PhD
  • Taipei, Taiwan, 112201
    • Recruiting
    • Taipei Veterans General Hospital
    • Principal Investigator: I-Ming Chen, MD, PhD
• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 9DU
      • Recruiting
      • Oxford University Hospitals NHS Trust - John Radcliffe Hospital
      • Principal Investigator: Dominic Howard, BM B.Ch MA DPhil (Oxon) FRCS
• United States
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University Medical Center
      • Principal Investigator: Ahmed Abou-Zamzam, MD
    • Orange, California, United States, 92868
      • Recruiting
      • University of California Irvine Medical Center
      • Principal Investigator: Anthony Chau, MD
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis Medical Center
      • Principal Investigator: Mimmie Kwong, MD
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco UCSF Medical Center
      • Principal Investigator: Jade Hiramoto, MD
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health Medical Center
      • Principal Investigator: Lisa Bennett, MD, MS
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • MedStar Washington Hospital Center
      • Principal Investigator: Steven Abramowitz, MD
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Jacksonville
      • Principal Investigator: Young Erben, MD
    • Sarasota, Florida, United States, 34239
      • Recruiting
      • Sarasota Memorial Hospital
      • Principal Investigator: Deepak Nair, MD
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Ascension Via Christi Saint Francis
      • Principal Investigator: Chad Ammar, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky
      • Principal Investigator: Sam C Tyagi, MD
  • Maine
    • Portland, Maine, United States, 04102
      • Recruiting
      • Maine Medical Center
      • Principal Investigator: Kristina Giles, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Marc Schermerhorn, MD
    • Springfield, Massachusetts, United States, 01199
      • Recruiting
      • Baystate Medical Center
      • Principal Investigator: Matthew Kronick, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester
      • Principal Investigator: Randall DeMartino, MD
  • New York
    • Albany, New York, United States, 12208
      • Recruiting
      • Albany Medical College
      • Principal Investigator: Jeffrey Hnath, MD
    • New York, New York, United States, 10075
      • Recruiting
      • Northwell Health Lenox Hill Hospital
      • Principal Investigator: Alfio Carroccio, MD
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Westchester Medical Center
      • Principal Investigator: Igor Laskowski, MD
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Novant Health Forsyth Medical Center
      • Principal Investigator: Ray Workman, MD
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals, Cleveland Medical Center
      • Principal Investigator: Jae Cho, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Principal Investigator: Grace Wang, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Withdrawn
      • Prisma Health
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Withdrawn
      • Cardiovascular Surgery Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas Health Science Center at Houston
      • Principal Investigator: Rana Afifi, MD
    • Plano, Texas, United States, 75093
      • Recruiting
      • The Heart Hospital Baylor Plano
      • Contact: Elyza Guerrero
      • Principal Investigator: Dennis Gable, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medtronic Endurant II/IIs; 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.	Device: Medtronic Endurant II or Endurant IIs Stent Graft System; EVAR treatment with Medtronic Endurant II/IIs Stent Graft System
Experimental: Gore Excluder / Excluder Conformable; 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.	Device: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis; EVAR treatment with Excluder / Excluder Conformable Stent Graft System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Marc Schermerhorn, MD, Beth Israel Deaconess Medical Center, United States; Principal Investigator: Hence Verhagen, MD, Erasmus University Medical Center, Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: EVAR, AAA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: MDT21033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes