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

Condition(s) studied

Investigational drug(s) / intervention(s)

endovascular repair of the AAA: The Investigator will ensure that investigational devices are used only in subjects properly enrolled in the clinical study in accordance with the protocol. Subjects will undergo endovascular repair of their AAA. Procedural details may vary between sites, but will follow standard hospital protocol for EVAR and patient care management.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Primary safety success defined by the absence of major adverse events — up to 30 days after index procedure
  These major adverse events are defined as all-cause mortality, stroke, mycardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure and thromboembolic events (including limb occlusion and distal embolic events).
• Technical treatment success — At the primary procedure
  Proportion of subjects who experience successful, delivery and deployment of all required EXCC Device components annd successful removal of EXCC device delivery catheter(s)
• Clinical effectiveness success — From the day after the initial procedure up to 3 years after the initial procedure (which is the end of the follow up period for this registry
  Effectiveness defined as absence of type I endoleak at each visit, Type III endoleak at the 12 month visit, migration (10 mm or more) between the one month and the 12 month visit, AAA enlargement \>5 mm with or without intervention between the one month and the 12 month visit, AAA rupture through the 12 month visit, conversion to open repair through the 12 month visit, limb occlusion

Trial sites (8)