Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial
Study Details
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 |
|---|---|---|
|
N/A |
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:
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Medtronic Endurant II/IIs Stent Graft System
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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
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
- Sac Regression [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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject and the treating physician agree that the subject will return for all required followup visits
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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
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Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man)
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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:
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Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this study
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Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator
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Subject has an aneurysm that is:
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Suprarenal/pararenal/juxtarenal
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Isolated ilio-femoral
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Mycotic
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Inflammatory
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Pseudoaneurysm
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Concomitant or prior dissection involving the abdominal aorta or iliac arteries
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Ruptured, including leaking
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Symptomatic AAA
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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.
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Subject requires emergent aneurysm treatment, for example, trauma or rupture
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Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome
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Subject has previously undergone surgical treatment for abdominal aortic aneurysm
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Planned use of aorto-uni-iliac (AUI) main body device
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Any planned additional device during index procedure (e.g. endostaple or anchor, Iliac branch endoprosthesis, sac or side branch embolization etc.)
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Subject has an estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73m2 or subject is on dialysis
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Subject has a systemic infection who may be at increased risk of endovascular graft infection
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Subject has a psychiatric or other condition that may interfere with the study
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Subject is a female of childbearing potential in whom pregnancy cannot be excluded
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Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment
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Subject belongs to a vulnerable population per investigator's judgment
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Subject has an active COVID-19 infection or relevant history of COVID- 19
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prisma Health | Greenville | South Carolina | United States | 29615 |
| 2 | The Heart Hospital Baylor Plano | Plano | Texas | United States | 75093 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT21033