RECRUITING

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-05
Study Completion:2029-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05378347

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject and the treating physician agree that the subject will return for all required followup visits
  2. * 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
  3. * Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man)
  4. * 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.
  1. * Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial
  2. * Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
  3. * Subject has an aneurysm that is:
  4. 1. Suprarenal/pararenal/juxtarenal
  5. 2. Isolated ilio-femoral
  6. 3. Mycotic
  7. 4. Inflammatory
  8. 5. Pseudoaneurysm
  9. 6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries
  10. 7. Ruptured
  11. 8. Symptomatic AAA
  12. * 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.
  13. * Subject requires emergent aneurysm treatment, for example, trauma or rupture
  14. * Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome
  15. * Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease
  16. * Planned use of aorto-uni-iliac (AUI) main body device
  17. * 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.
  18. * Planned coverage of the internal iliac artery/arteries
  19. * Subject has an estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73m2 or subject is on dialysis
  20. * Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion
  21. * Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion
  22. * Subject is of childbearing potential in whom pregnancy cannot be excluded
  23. * Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
  24. * Subject belongs to a vulnerable population per investigator's judgment
  25. * Subject has an active COVID-19 infection or relevant history of COVID- 19

Contacts and Locations

Study Contact

ADVANCE Trial Clinical Study Team
CONTACT
763-514-4000
rs.advancestudy@medtronic.com

Principal Investigator

Marc Schermerhorn, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center, United States
Hence Verhagen, MD
PRINCIPAL_INVESTIGATOR
Erasmus University Medical Center, Netherlands

Study Locations (Sites)

Loma Linda University Medical Center
Loma Linda, California, 92354
United States
University of California Irvine Medical Center
Orange, California, 92868
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
University of California San Francisco UCSF Medical Center
San Francisco, California, 94143
United States
Denver Health Medical Center
Denver, Colorado, 80204
United States
Yale Center for Clinical Investigation
New Haven, Connecticut, 06519
United States
Medstar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
Northside Hospital Forsyth
Atlanta, Georgia, 30342
United States
Northshore University Health System
Skokie, Illinois, 60076
United States
Ascension Via Christi Saint Francis
Wichita, Kansas, 67214
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Maine Medical Center
Portland, Maine, 04102
United States
VA Maryland Health Care System
Baltimore, Maryland, 21201
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Albany Medical College
Albany, New York, 12208
United States
Northwell Health Lenox Hill Hospital
New York, New York, 10075
United States
Westchester Medical Center
Valhalla, New York, 10595
United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103
United States
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Prisma Health
Greenville, South Carolina, 29615
United States
Cardiovascular Surgery Clinic
Memphis, Tennessee, 38120
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093
United States
University of Virginia Health System
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: Medtronic Cardiovascular

  • Marc Schermerhorn, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center, United States
  • Hence Verhagen, MD, PRINCIPAL_INVESTIGATOR, Erasmus University Medical Center, Netherlands

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-05
Study Completion Date2029-05

Study Record Updates

Study Start Date2023-01-05
Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

  • EVAR, AAA

Additional Relevant MeSH Terms

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