Post-operative CT Follow up Measurement After Nellix Endoprosthesis Implantation in Patients With Abdominal Aortic Aneurysms.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Primary Endpoint
- Changes in the infrarenal neck morphology (below the renal arteries)
Study Overview
Brief Summary
Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix Endoprosthesis.
Detailed Description
Rationale:
In patients with abdominal aortic aneurysms the Nellix Endoprosthesis aims to reduce post-operative complications and subsequent re-intervention rates. Using two stents covered with two polymer filled endobags used for sealing and excluding the aneurysm sac. Preliminary results show promising results in reducing these complications. The new endoprosthesis is not only different in treatment but also in follow up imaging. To date it is unknown how the stent, polymer filled endobags and aneurysm appear in CT imaging in short and long term follow up.
Objective:
To assess and describe the normal computed tomography (CT) appearance at 30 days and 1 year after implantation of the Nellix Endoprosthesis.
Study population:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who underwent endovascular abdominal aneurysm repair using the Nellix endoprosthesis
Exclusion Criteria
- •No specific exclusion criteria
Outcomes
Primary Outcomes
Changes in the infrarenal neck morphology (below the renal arteries)
Time Frame: 1 year
Changes in the thrombus in the aneurysm sac
Time Frame: 1 year
Changes in the aneurysm wall and geometry
Time Frame: 1 year
Changes in the cobalt-chromium stent and their lumen
Time Frame: 1 year
Changes in the polymer-filled endobags Using anonymous patient data a database will be created an securely stored. Patient consent for study participation will be attained before accessing patient files
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Michel Reijnen
M.D., PhD
Rijnstate Hospital