Randomized controlled trials (RCT)
We believe in arming physicians with high-level, real-world clinical evidence to make informed treatment decisions and build the base of aortic knowledge. By investing in head-to-head randomized control trials, we aim to push the boundaries of established aortic evidence to accelerate future innovations that benefit all.
ADVANCE randomized controlled trial
ADVANCE randomized controlled trial
EndurAnt stent graft system vs. ExcluDer endoprosthesis – a global prospectiVe, rANdomized Clinical trial in sac rEgression
Advancing the understanding of factors that contribute to abdominal endovascular aneurysm repair (EVAR) durability through robust clinical evidence generation to better patient outcomes and care.
For safety information on all other third-party devices used, visit their respective websites.
About the trial
ADVANCE is designed to empower physician’s decisions as the first head-to-head EVAR randomized controlled trial aimed to advance sac regression evidence to improve patient outcomes. One-year sac regression is a robust indicator of EVAR durability and is linked to long-term outcomes, including mortality and secondary reinterventions.1
Aneurysm sac regression is a key indicator2 for EVAR success.
Latest data suggests aneurysm sac regression is associated with better long-term outcomes.2 Cohort that demonstrated sac regression at one year had significantly better outcomes than stable and expanding sac cohorts.2
Freedom from all-cause mortality
Head-to-head
Many factors are theorized as contributing to sac regression, including device characteristics. The aim of this study is to shed further light on the underlying factors of sac regression and specific key outcomes between the Endurant™ II/IIs AAA stent graft system and GORE™* Excluder™*/Excluder™* Conformable.
The Medtronic Endurant™ II/IIs stent graft system3
Material
Nitinol and polyester (PET)
Fixation
Suprarenal fixation and m-stent sealing
Design
2- or 3-piece bifurcated graft
The Gore™* Excluder™*/Excluder™* Conformable endoprosthesis4,5
Material
Nitinol and polytetra-fluoroethylene (ePTFE)
Fixation
Infrarenal fixation and z-stent sealing
Design
2-piece bifurcated graft
Learn how you can address sac regression with the Endurant™ II/IIs stent graft.
Primary endpoint
The primary objective of this trial is to evaluate sac regression outcomes of Endurant™ II/IIs stent graft system and GORE™* Excluder™*/Excluder™* Conformable at one-year post-EVAR procedure.
Secondary endpoints
- Sac regression (diameter/volume)
- All-cause mortality (ACM)
- Secondary interventions
- Type I/type II endoleaks
Ancillary objectives
Procedure
- Sustained treatment success = technical success + freedom from key clinical outcomes, including secondary interventions
- Adjunctive procedures comparison (including cuff usage) and deployment accuracy comparison
Safety
- Major adverse events (MAE), aneurysm-related mortality (ARM)
- Renal complications and decline
- Systemic inflammation markers
Imaging
- Type III endoleaks
- Migration
- Aortic neck dilatation
- Limb occlusion
~ 500 subjects†
AAA with diameter ≥ 50 mm (women) and ≥ 55 mm (men) and adequate anatomy‡ to receive both the Endurant™ II/IIs system and GORE™* Excluder™*/Excluder™* Conformable
50+ centers worldwide
United States, European Union, Japan, and Taiwan
5 years of follow-up
Computed tomography angiography (CTA) imaging-based follow-up at one month, one year, and annual follow-up through five years
Global, prospective, multicenter, randomized (1:1) trial
- Endurant™ II/IIs stent graft system, or
- GORE™* Excluder™*/Excluder™* Conformable
For details about locations for the ADVANCE RCT, visit clinicaltrials.gov.
Additional information
To learn more about EVAR therapy, the procedure, and our resources, please visit Medtronic Academy.
Visit clinicaltrials.gov for more information about the ADVANCE randomized controlled trial and for a complete list of subject selection criteria.
*™ Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
† Bayesian Goldilocks analysis will be performed to determine if sample size should be increase up to max 900 to achieve appropriate trial power.
‡ Adequate anatomy to be determined by region-specific criteria. Please visit clinicaltrials.gov for more information.
1. Bӧckler D, Li C, Dansey K, et al. Sac regression is associated with lower all-cause mortality after contemporary endovascular aneurysm repair — a new paradigm for success. Presented online at ESVS 34th Annual Meeting, October 6, 2020.
2. O’Donnell TFX, Deery SE, Boitano LT, et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival. J Vasc Surg. 2019;69(2):414-422.
3. Endurant™ stent graft system Instructions for Use. 2020.
4. GORE™* Excluder™* Conformable AAA endoprosthesis Instructions for Use. 2021.
5. GORE™* Excluder™* AAA Endoprosthesis Instructions for Use. 2021.
