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

Purpose

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation > 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.

Eligibility
Age: 18 Years and older (Adult, Older Adult)
Gender: All
Disease condition: No healthy volunteers

Procedures
Primary safety success defined by the absence of major adverse events [ Time Frame: up to 30 days after index procedure ]
These major adverse events are defined as all-cause mortality, stroke, myocardial infarction, bowel ischemia, paraplegia, respiratory failure, renal failure and thromboembolic events (including limb occlusion and distal embolic events).

Technical treatment success [ Time Frame: At the primary procedure ]
Proportion of subjects who experience successful, delivery and deployment of all required EXCC Device components and successful removal of EXCC device delivery catheter(s).

Clinical effectiveness success [ Time Frame: 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.
Additional study details and procedures will be explained by the study team.

Additional eligibility criteria and study procedure details can be explained by the study team. Please call or email:
jenny.zwetsloot@catharinaziekenhuis.nl
+31040-239-6349

Age

18 to 65
65 and over

Gender

Male
Female

Monetary compensation

No

Can be done from home

No

Keywords

Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases, Cardiovascular Diseases

Principal Investigator

Marc, Catharina Sambeek, Eindhoven, Prof. Dr

Department

Heart and Vascular

Contact Information

jenny.zwetsloot@catharinaziekenhuis.nl

‪+31 (0)40 239 6349‬


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