Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis In the Treatment of Abdominal Aortic Aneurysms
About the study
Who can take part
INCLUSION CRITERIA
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
Saccular aneurysm, unless it meets inclusion criteria of rapid growth (>5 mm in a 6 month period) or maximum diameter of (≥50 mm)
EXCLUSION CRITERIA
Exclusion Criteria:
- Mycotic or ruptured aneurysm
- 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
Study Locations
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How to Apply
Study’s details
Contition
Abdominal Aortic Aneurysm (AAA)
Age (in years)
18+
Participants needed
156
Est. Completion Date
Jan 31, 2026
Treatment type
Observational [Patient Registry]
Sponsor
Catharina Ziekenhuis Eindhoven
ClinicalTrials.gov identifier
NCT03743142
Study number
EXCEL
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