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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02440113
Other study ID # WP-14-857
Secondary ID
Status Completed
Phase N/A
First received January 12, 2015
Last updated July 14, 2016
Start date December 2014
Est. completion date August 2015

Study information

Verified date July 2016
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Rijnstate Hospital Local review board (board of directors)
Study type Observational

Clinical Trial Summary

Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix Endoprosthesis.


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:

Approximately a total of 100 patients who underwent endovascular aneurysm repair using Nellix endoprosthesis in three different hospitals. The population is comprised of approximately fifty patients from Rijnstate Ziekenhuis Arnhem and twenty-five each from St. Antonius Nieuwegein and St. Elisabeth Tilburg.

Design and methods:

The study is designed as a multicenter retrospective cohort. Using CT-scans from regular follow up dates (30 days and 1 year) imaging will be retrospectively assessed using medical imaging software. Main study endpoints are defined as followed:

1. Changes in the infrarenal neck morphology (below the renal arteries)

2. Changes in the thrombus in the aneurysm sac

3. Changes in the aneurysm wall and geometry

4. Changes in the cobalt-chromium stent and their lumen

5. 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.

Nature and extent of the burden and risk associated with participation, benefit and group relatedness:

The study will not bring an extra burden or risk for patients participating. Patients are encouraged to participate to improve insight for patients with the same disease and might improve health care in the future for this group of patients.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who underwent endovascular abdominal aneurysm repair using the Nellix endoprosthesis

Exclusion Criteria:

- No specific exclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Intervention

Device:
Nellix
Nellix Implantation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the infrarenal neck morphology (below the renal arteries) 1 year No
Primary Changes in the thrombus in the aneurysm sac 1 year No
Primary Changes in the aneurysm wall and geometry 1 year No
Primary Changes in the cobalt-chromium stent and their lumen 1 year No
Primary 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 1 year No
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