Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

Condition
Abdominal Aortic Aneurysm
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University Medical Center, Loma Linda, California, United States, 92354

Orange

University of California Irvine Medical Center, Orange, California, United States, 92868

Sacramento

University of California Davis Medical Center, Sacramento, California, United States, 95817

San Francisco

University of California San Francisco UCSF Medical Center, San Francisco, California, United States, 94143

Denver

Denver Health Medical Center, Denver, Colorado, United States, 80204

New Haven

Yale Center for Clinical Investigation, New Haven, Connecticut, United States, 06519

Washington

Medstar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Jacksonville

Mayo Clinic Jacksonville, Jacksonville, Florida, United States, 32224

Sarasota

Sarasota Memorial Hospital, Sarasota, Florida, United States, 34239

Atlanta

Northside Hospital Forsyth, Atlanta, Georgia, United States, 30342

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

20 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2029-05