Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Purpose
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)
Eligibility
- Eligible Ages
- Over 20 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Subject and the treating physician agree that the subject will return for all required follow up 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) or as stated otherwise in regional addenda. - 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Clinical Events Committee members as well as key sponsor team members will be blinded
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
|
Recruiting Locations
Loma Linda University Medical Center
Loma Linda, California 92354
Loma Linda, California 92354
Hoag Hospital
Newport Beach, California 92663
Newport Beach, California 92663
Contact:
Allen Murga
Allen Murga
University of California Irvine Medical Center
Orange, California 92868
Orange, California 92868
University of California San Francisco UCSF Medical Center
San Francisco, California 94143
San Francisco, California 94143
Denver Health Medical Center
Denver, Colorado 80204
Denver, Colorado 80204
Yale Center for Clinical Investigation
New Haven, Connecticut 06519
New Haven, Connecticut 06519
Medstar Washington Hospital Center
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Sarasota Memorial Hospital
Sarasota, Florida 34239
Sarasota, Florida 34239
Northside Hospital Forsyth
Atlanta, Georgia 30342
Atlanta, Georgia 30342
Contact:
Siddharth Patel
Siddharth Patel
Northshore University Health System
Skokie, Illinois 60076
Skokie, Illinois 60076
Ascension Via Christi Saint Francis
Wichita, Kansas 67214
Wichita, Kansas 67214
University of Kentucky
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Maine Medical Center
Portland, Maine 04102
Portland, Maine 04102
VA Maryland Health Care System
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Baystate Medical Center
Springfield, Massachusetts 01199
Springfield, Massachusetts 01199
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Contact:
Jeffrey Jim
Jeffrey Jim
Mayo Clinic Rochester
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Northwell Health Lenox Hill Hospital
New York, New York 10075
New York, New York 10075
Westchester Medical Center
Valhalla, New York 10595
Valhalla, New York 10595
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
University Hospitals, Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
The Heart Hospital Baylor Plano
Plano, Texas 75093
Plano, Texas 75093
Contact:
Elyza Guerrero
Elyza Guerrero
University of Virginia Health System
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Cardiovascular
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. Approximately 600 subjects are planned to be enrolled at up to 100 sites globally. 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.