Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms

About this trial

Last updated a year ago

Study ID

EXCeL

Status

Active not recruiting

Type

Observational

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 4 months ago

What is this trial about?

EVAR continues to evolve as a treatment option for AAA. New devices which are specifically designed to perform adequately across the spectrum of potential anatomic presentations for infrarenal EVAR are needed. The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the EXCeL Registry. This study will assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC Device) in patients who meet the IFU anatomic criteria (≥15mm proximal neck length and ≤90˚ proximal neck angulation; and ≥10mm proximal neck length and ≤60˚ proximal neck angulation) and in patients with challenging anatomic presentation that may present outside the IFU anatomic criteria. Successful outcomes from this study will provide evidence to support the CEXC Device as an option for expanding EVAR to a broader patient population with more challenging anatomic presentations.

What are the participation requirements?

Inclusion Criteria

1. AAA meeting any of the following criteria:

* Maximum diameter ≥50 mm

* Rapid growth (>5 mm in a 6 month period)

* Non-ruptured AAA presenting with clinical symptoms 2 Adequate anatomy to receive the CEXC Device, including:

* Adequate iliac / femoral access

* Infrarenal aortic neck diameter 16-32 mm

* Distal iliac artery seal zone ≥10 mm

* Iliac artery diameter 8-25 mm 3. An Informed Consent Form (ICF) dated and signed by subject 4. Male or infertile female* 5. Able to comply with protocol requirements including following-up 6. Life expectancy >2 years 7. Age ≥18 years * Infertile female - condition which prevents pregnancy, e.g., hysterectomy, tubal ligation or post-menopausal for greater than 1 year

Exclusion Criteria

1. Mycotic or ruptured aneurysm

2. Saccular aneurysm, unless it meets inclusion criteria of rapid growth (>5 mm in a 6 month period) or maximum diameter of (≥50 mm)

3. Known concomitant thoracic aortic aneurysm which requires surgical intervention 4. Renal insufficiency defined as creatinine >2.5 mg/dL or GFR <30 mL/min/1.73 m2

5. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta 6. Participating in another investigational device study within 1 year of treatment 7. Systemic infection which may increase the risk of endovascular graft infection 8. Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome 9. Planned concomitant surgical procedure or major surgery within 30 days of treatment date, including planned branched, snorkel or chimney procedures 10. Known sensitivities or allergies to the device materials 11. Use of non-Gore stent grafts in initial procedure