NCT02438605CompletedNot Applicable
Dynamic CT Imaging After Nellix Endoprosthesis Implantation
Rijnstate Hospital1 site in 1 country10 target enrollmentStarted: April 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS
Study Overview
Brief Summary
The Nellix Endovascular Sealing Prosthesis (EVAS) endoprosthesis is a new device aimed at prophylactic treatment of abdominal aortic aneurysms. In regular follow up conventional CT-imaging is used for surveillance. In this study dynamic CT imaging in patients pre- and post-operative will be assessed for device changes and anatomical variances.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Nellix implantation
Exclusion Criteria
- •Use of chimneys or combined with other stent graft material
Outcomes
Primary Outcomes
Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS
Time Frame: 1 month
Secondary Outcomes
- Dynamic changes in common iliac artery morphology after EVAS.(1 month)
- Dynamic changes in neck morphology after EVAS(1 month)
Investigators
Michel Reijnen
M.D., PhD.
Rijnstate Hospital
Study Sites (1)
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