Aortic endovascular repair
Randomized controlled trials (RCT)
View randomized controlled trials (RCT) for aortic endovascular repair.
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
Endurant stent graft system versus 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
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 AAA 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 AAA endoprosthesis4,5
Material
Nitinol and polytetra-fluoroethylene (ePTFE)
Fixation
Infrarenal fixation and sealing cuff
Design
2-piece bifurcated graft
Learn how you can address sac regression with the Endurant™ II/IIs stent graft.
Risks associated with EVAR procedures may include rupture, conversion to open repair, or secondary procedures.
Primary endpoint
The primary objective of this trial is to evaluate sac regression outcomes of Endurant™ II/IIs AAA 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
About 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 plus centers worldwide
United States, European Union, Japan, and Taiwan
Five 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
HERCULES randomized controlled trial
A global prospective, randomized clinical trial evaluating and comparing endosuture aneurysm repair (ESAR) and endovascular aneurysm repair (EVAR) in wide infrarenal proximal aortic necks
For safety information on all other third-party devices used, visit their respective websites.
About the trial
The HERCULES trial is an investigator-driven study in collaboration with Professor M.M.P.J. Reijnen, M.D., Professor K. Donas, M.D., and Medtronic. Rijnstate is the sponsor of the study.
HERCULES is a randomized controlled clinical trial (RCT) designed to prospectively compare ESAR to EVAR clinical outcomes in treatment of infrarenal abdominal aortic aneurysms (AAA) in patients with wide proximal neck diameters (≥ 28 mm and ≤ 32 mm).
EVAR has been established as a safe and effective repair for AAA. However, recent published literature shows wide infrarenal necks treated with EVAR are at a greater risk for loss of proximal seal and related events.6–9 Recent ANCHOR data shows promising results in treating wide necks with ESAR when compared to EVAR wide neck literature data.6–10
Wide necks are§:
- 6.7 times more likely to have type Ia endoleak (EL) (p = 0.001)
- 10 times more likely to have sac expansion (p = 0.009)
- 5.1 times more likely to rupture (p = 0.01)
(N = 6,602 f/u ranged from 2.7 years (mean) to 3.9 years)6
ANCHOR registry wide neck cohort three-year data (n = 72)10
98.5% three-year freedom from (FF) type Ia endoleak
100% three-year FF secondary procedures to treat type Ia
100% three-year FF migration
100% three-year FF rupture
93.4% (28/30)◊ sac regression/stable
66.7% (20/30)◊ sac regression
The HERCULES trial aims to provide a foundation to further characterize the clinical outcomes of treatment for patients with infrarenal AAA with wide proximal neck diameters by comparing the clinical outcomes of Endurant™ II/IIs stent graft plus Heli-FX™ EndoAnchor™ system to EVAR with Endurant™ II/IIs stent graft system.
Learn more about Heli-FX™ EndoAnchor™ system, Endurant™ II/IIs stent graft system, ENGAGE data, and ANCHOR data.
EVAR
Endurant™ II/IIs AAA stent graft system
ESAR
Endurant™ II/IIs stent graft plus Heli-FX™ EndoAnchor™ system
300 subjects
Infrarenal AAA with wide proximal neck diameters (≥ 28 mm and ≤ 32 mm)
Up to 40 global centers
United States and Europe
Follow-up at one month, one year, and annual follow-up through five years
Post-market, prospective, global, multicenter, randomized (1:1), two-arm superiority trial
ESAR with Endurant™ II/IIs stent graft system plus Heli-FX™ EndoAnchor™ system, or EVAR with Endurant™ II/IIs stent graft system
Primary endpoint
Composite endpoint based on core lab reported data from computed tomography (CT) with contrast imaging of freedom from:
- Type Ia endoleak, and
- Migration of the proximal portion of the stent graft ≥ 5 mm (compared to one-month imaging), and
- Aneurysm sac growth ≥ 5 mm (compared to one-month imaging).
Secondary endpoints
Evaluated using core lab reported data:
- Freedom from type Ia endoleak
- Freedom from migration of the proximal portion of the stent graft ≥ 5 mm (compared to one-month imaging)
- Freedom from aneurysm sac growth ≥ 5 mm (compared to one-month imaging)
- Freedom from neck dilatation ≥ 3 mm
About the trial
The SOCRATES trial is a collaborative research effort between the Foundation for Cardiovascular Research and Education (FCRE) and Medtronic.
SOCRATES is a randomized controlled clinical trial (RCT) designed to prospectively compare clinical outcomes between endosuture aneurysm repair (ESAR) to fenestrated endovascular repair (FEVAR) in treatment of infrarenal abdominal aortic aneurysms (AAA) in patients with short proximal neck lengths (≥ 4 mm and ≤ 15 mm) and a minimum infrarenal sealing zone length of 8 mm.
Both ESAR and FEVAR have been observed to be durable options for treating patients with short neck aneurysms.11,12 SOCRATES aims to provide clinicians with level-1 clinical evidence to inform the treatment algorithms and therapy selection for patients with short neck aneurysms.
Devices used: Endurant™ II/IIs stent graft and Heli-FX™ EndoAnchor™ system (ESAR) versus Cook Zenith™* fenestrated or Terumo fenestrated Anaconda™*¶ (FEVAR)
About 200 subjects
Infrarenal AAA with short proximal neck lengths (≥ 4 mm and ≤ 15 mm) and minimum infrarenal sealing zone of 8 mm
Up to 40 sites may be included
United States and Europe
Follow-up at one month, one year, two years, and three years
Prospective, global, multicenter, randomized (1:1), two-arm, non-inferiority trial
- ESAR with Endurant™ II/IIs stent graft system plus Heli-FX™ EndoAnchor™ system, or
- FEVAR with Cook Zenith™* fenestrated or Terumo fenestrated‡ Anaconda™*
Effectiveness
Composite of technical success at index procedure, and freedom from type Ia or type III endoleak, freedom from aneurysm-related mortality (ARM), and freedom from secondary reinterventions through 12 months post-index procedure.
Safety
Freedom from major adverse events through 30 days, including:
- All-cause mortality
- Bowel ischemia
- Myocardial infarction
- Respiratory failure
- Disabling stroke
- Access-related complications
- Procedural blood loss > 1,000 cc
- Permanent paraplegia or paraparesis
- Renal complications
A full list of endpoints can be found on the SOCRATES clinicaltrials.gov site.