Clinical data for GORE® EXCLUDER® Conformable AAA Endoprosthesis
EXCLUDER® Conformable Device U.S. Pivotal Trial1,2
The pivotal trial follows 175 patients up to 5 years.
Designed to examine safety and efficacy in complex aortic anatomies
Prospective, non-randomized study with 2 arms:
- Short neck sub-study: subjects with AAA aortic neck angulation ≤ 60º and infrarenal aortic neck length ≥ 10 mm.
- High neck angulation sub-study: subjects with AAA aortic neck angulation > 60º and ≤ 90º and infrarenal aortic neck length ≥ 10 mm.
Subjects by neck characteristic | ||
|---|---|---|
| Neck length | Neck angle ≤ 60° | Neck angle > 60° to ≤ 90° |
| ≥ 15mm | 57 | 74 |
| ≥ 10mm to < 15mm | 23 | 21 |
Durable performance in hostile necks.1,2,a
- 98.9% procedural technical success
- 100% freedom from aneurysm-related mortality
- 98.3% freedom from device-related SAEs
Hear trial investigators discuss the importance of trial design and device performance in challenging aortic necks.
Outcomes through 36 months
| Aortic neck characteristics | ≥ 15 mm ≤ 60° | ≥ 10 - < 15 mm ≤ 60° | ≥ 15 mm > 60° - ≤ 90° | ≥ 10 - < 15 mm > 60° - ≤ 90° | All necks |
|---|---|---|---|---|---|
| Subjects totala | 57 | 23 | 74 | 21 | 175 |
| Procedural technical successb | 100% | 100% | 97.3% | 100% | 98.9% |
| Device compression (ie, kink) | 0% | 0% | 1.4% | 0% | 0.6% |
| Migration | 0% | 0% | 0% | 0% | 0% |
| Type I endoleakc | 0% | 0% | 5.4% | 0% | 2.3% |
| Type III endoleak | 0% | 0% | 0% | 0% | 0% |
| Reintervention | 10.5% | 4.3% | 17.6% | 4.8% | 12% |
| Conversion to open repair | 0% | 0% | 4.1% | 0% | 1.7% |
| AAA rupture | 0% | 0% | 1.4% | 0% | 0.6% |
| Aneurysm-related mortality | 0% | 0% | 0% | 0% | 0% |
| Device-related SAEs | 0% | 0% | 4.10% | 0% | 1.70% |
| AAA sac diameter: ≥ 5 mm decrease | 58.1% | 58.3% | 42.5% | 60.0% | 52.4% |
| AAA sac diameter: no changed | 32.6% | 25.0% | 37.5% | 20.0% | 32.4% |
| AAA sac diameter: ≥ 5mm increase | 9.3% | 16.7% | 20.0% | 20.0% | 15.2% |
See more clinical datae
Related pages
a. Outcomes through 36 months
b. Technical success was not achieved in 2 subjects with Type I endoleaks on completion angiography; these resolved prior to the first postoperative scan.
c. All Type 1 endoleaks occurred prior to 12-month window and resolved without treatment.
d. AAA sac diameter assessed at 36-month visit.
e. Gore products referenced within, if any, are used within their approved / cleared indications. Gore does not have knowledge of the indications and approval / clearance status of non-Gore products or surgical techniques. Gore makes no representations as to the diagnoses, surgical techniques, medical conditions or other factors that may be described in this article. The reader is advised to contact respective manufacturer(s) for current and accurate information.
- Assessment of the GORE EXCLUDER Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms. NLM Identifier: NCT02489539. Published July 3, 2015. Updated August 13, 2025. Accessed September 12, 2025. https://clinicaltrials.gov/ct2/show/NCT02489539
- Data on file.
- Rhee R, Almadani M, Yamanouchi D, et al. Early results from the pivotal trial substudy of the GORE® EXCLUDER® Conformable Endoprosthesis in angulated necks. Journal of Vascular Surgery 2025;81(2):342-350.e2.
- Rhee R, Oderich G, Han S, et al. One year results of the GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) system in the United States regulatory trial. Journal of Vascular Surgery 2022;76(4)951-959.e2.
- Suckow BD, Oderich GS, Almadani MW, et al. Five-year pivotal trial outcomes of the Gore Excluder Conformable Endoprosthesis implanted in abdominal aortic aneurysms with short non-angulated infrarenal seal zones. Journal of Vascular Surgery. 2025;82(3):793-801.e1.
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
INDICATIONS FOR USE: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (AAA) disease and who have appropriate anatomy as described below: Adequate iliac/femoral access; Infrarenal aortic neck treatment diameter range of 16-32 mm and a minimum aortic neck length of 10 mm; Proximal aortic neck angulation ≤ 90°; Iliac artery treatment diameter range of 8-25 mm and iliac distal vessel seal zone length of at least 10 mm. Aortic Extender Endoprosthesis and Iliac Extender Endoprosthesis Components are intended to be used after deployment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis. These extensions are intended to be used when additional length and/or sealing for aneurysmal exclusion is desired.
CONTRAINDICATIONS: The GORE® EXCLUDER® Conformable AAA Endoprosthesis is contraindicated in patients with known sensitivities or allergies to the device materials. All components of the GORE® EXCLUDER® Conformable Endoprosthesis contain expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene (FEP), nitinol (nickel-titanium alloy) and gold. Patients with systemic infection who may be at increased risk of endovascular graft infection.