Dynamic CT Imaging After Nellix Endoprosthesis Implantation

Completed

• Conditions: Aortic Aneurysm
• Interventions: Device: Nellix

• Registration Number: NCT02438605
• Lead Sponsor: Rijnstate Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-08
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Nellix implantation

Exclusion Criteria

• Use of chimneys or combined with other stent graft material

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group	Nellix	Patients eligible for AAA repair using Nellix and willing to participate in this trial.

Primary Outcome Measures

Name	Time	Method
Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS	1 month

Secondary Outcome Measures

Name	Time	Method
Dynamic changes in common iliac artery morphology after EVAS.	1 month
Dynamic changes in neck morphology after EVAS	1 month

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands