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

• ClinicalTrials.gov Identifier: NCT05378347
• Recruitment Status: Recruiting
• First Posted: May 18, 2022
• Last Update Posted: March 21, 2023
• Sponsor: Medtronic Cardiovascular
• Information provided by (Responsible Party): Medtronic Cardiovascular

Study Description

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 will be randomized and imaging will be collected at all follow-up time points to assess the primary endpoint.

Condition or disease	Intervention/treatment	Phase
Abdominal Aortic Aneurysm; Abdominal Aortic Aneurysm Greater Than 5.5 Centimeters in Male (Disorder); Abdominal Aortic Aneurysm Greater Than 5.0 Centimeters in Female (Disorder)	Device: Medtronic Endurant II or Endurant IIs Stent Graft System; Device: Gore Excluder or Gore/ Excluder Conformable AAA Endoprosthesis	Not Applicable

Detailed Description:

This is a post-market, prospective, interventional, nonblinded, global, multi- center, randomized, dual-arm clinical study. The primary objective of this study 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 will be 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 will be collected pre- and post-procedure at discharge, at 30 days, and once a year until the 5-year follow-up is completed.

Product Names:

• Medtronic Endurant II/IIs Stent Graft System
• Gore Excluder and/or Gore Excluder Conformable AAA Endoprosthesis Imaging will be collected for all follow-up time points and be evaluated by a core lab for the key primary and secondary objectives.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Clinical Events Committee members as well as key sponsor team members will be blinded
• Primary Purpose: Treatment
• Official Title: Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression
• Actual Study Start Date: January 5, 2023
• Estimated Primary Completion Date: May 2025
• Estimated Study Completion Date: May 2029

Arms and Interventions

Arm	Intervention/treatment
Experimental: Medtronic Endurant II/IIs; Subjects will be 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 will be 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

Outcome Measures

Primary Outcome Measures :

1. Sac Regression [ Time Frame: 12 months ]
   Proportion of patients with sac regression at 1 year in accordance with SVS guidelines as the reduction in maximum diameter by >= 5 mm when compared to the first CT imaging study obtained after index procedure.

Secondary Outcome Measures :

1. Aneurysm sac change by diameter as a continuous variable [ Time Frame: 12 months and annually to 5 years ]
2. Aneurysm sac change by volume incidence rate [ Time Frame: 12 months and annually to 5 years ]
3. Type II endoleak incidence rate [ Time Frame: 30 days, 12 months and annually to 5 years ]
4. Type I endoleak incidence rate [ Time Frame: 30 days,12 months and annually to 5 years ]
5. Secondary intervention incidence rate [ Time Frame: 30 days, 12 months and annually to 5 years ]
6. All cause mortality incidence rate [ Time Frame: 30 days, 12 months and annually to 5 years ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man)
• Accepts Healthy Volunteers: No

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 study 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 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 study
• 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, including leaking
  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. Irregular calcium and / or plaque may compromise the fixation and sealing of the implantation sites.
• 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 treatment for abdominal aortic aneurysm
• Planned use of aorto-uni-iliac (AUI) main body device
• Any planned additional device during index procedure (e.g. endostaple or anchor, Iliac branch endoprosthesis, sac or side branch embolization etc.)
• 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
• Subject has a psychiatric or other condition that may interfere with the study
• Subject is a female 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

Contacts and Locations

Contacts

Contact: ADVANCE Trial Clinical Study Team; 763-514-4000; rs.advancestudy@medtronic.com

Locations

United States, District of Columbia

Medstar Washington Hospital Center; Recruiting

Washington, District of Columbia, United States, 20010

Principal Investigator: Steven Abramowitz, MD

United States, Florida

Mayo Clinic Jacksonville; Recruiting

Jacksonville, Florida, United States, 32224

Principal Investigator: Young Erben, MD

Sarasota Memorial Hospital; Recruiting

Sarasota, Florida, United States, 34239

Principal Investigator: Deepak Nair, MD

United States, Massachusetts

Baystate Medical Center; Recruiting

Springfield, Massachusetts, United States, 01199

Principal Investigator: Matthew Kronick, MD

United States, Minnesota

Mayo Clinic Rochester; Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator: Randall DeMartino, MD

United States, North Carolina

Novant Health Forsyth Medical Center; Recruiting

Winston-Salem, North Carolina, United States, 27103

Principal Investigator: Ray Workman, MD

United States, Ohio

University Hospitals, Cleveland Medical Center; Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator: Jae Cho, MD

United States, Pennsylvania

Hospital of the University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator: Grace Wang, MD

United States, South Carolina

Prisma Health; Recruiting

Greenville, South Carolina, United States, 29615

Contact: Kya Spann

Principal Investigator: Mark Androes, MD

United States, Tennessee

Cardiovascular Surgery Clinic; Withdrawn

Memphis, Tennessee, United States, 38120

United States, Texas

The Heart Hospital Baylor Plano; Recruiting

Plano, Texas, United States, 75093

Contact: Elyza Guerrero

Principal Investigator: Dennis Gable, MD

Finland

Helsinki University Hospital; Recruiting

Helsinki, Finland, 00290

Principal Investigator: Maarit Venermo, MD, PhD

Italy

Azienda Ospedaliera Universitaria Federico II; Recruiting

Napoli, Italy, 80131

Principal Investigator: Umberto Marcello Bracale, MD, PhD

Sponsors and Collaborators

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

More Information

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT05378347
• Other Study ID Numbers: MDT21033
• First Posted: May 18, 2022
• Last Update Posted: March 21, 2023
• Last Verified: March 2023

• 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

Keywords provided by Medtronic Cardiovascular:

EVAR, AAA

Additional relevant MeSH terms:

Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Disease; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases