Post-operative CT Follow up After Nellix Endoprosthesis Implantation

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Post-operative CT Follow up Measurement After Nellix Endoprosthesis Implantation in Patients With Abdominal Aortic Aneurysms.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440113
• Other study ID #: WP-14-857
• 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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Endovascular Aortic Repair
• Nellix Endovascular Sealing

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