Clinical Trials Logo
  1. Home
  2. Aortic Aneurysm
  3. NCT02438605
  4. Details
NCT02438605 Clinical Trial

Dynamic CT Imaging After Nellix Endoprosthesis Implantation

Aortic Aneurysm Clinical Trial

Official title:
Dynamic CT Imaging After Nellix Endoprosthesis Implantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02438605
Other study ID # StM 596
Secondary ID
Status Completed
Phase N/A
First received May 6, 2015
Last updated June 30, 2016
Start date April 2015
Est. completion date February 2016

Study information
Verified date June 2016
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Nellix implantation

Exclusion Criteria:

- Use of chimneys or combined with other stent graft material

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Nellix

Locations
Country Name City State
Netherlands Rijnstate Hospital Arnhem

Sponsors (1)
Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in aortic aneurysm morphology as seen on dynamic CT after EVAS 1 month No
Secondary Dynamic changes in neck morphology after EVAS 1 month No
Secondary Dynamic changes in common iliac artery morphology after EVAS. 1 month No
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Enrolling by invitation NCT04035356 - HAART Annuloplasty Device Valve Repair Registry
Recruiting NCT02729064 - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose Phase 1
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Completed NCT02283307 - Dual Energy CT Urography With Reduced Iodinated Contrast N/A
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Terminated NCT01055275 - Cook Iliac Branch Graft Post-market Registry N/A
Completed NCT00615888 - Fast Track Management in Elective Open Infrarenal Aortic Aneurysm Repair N/A
Completed NCT03510793 - Microcirculation and Anesthesia in Vascular Surgery
Completed NCT03207568 - RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) N/A
Recruiting NCT05073991 - Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Not yet recruiting NCT01918982 - Circulating Endothelial Progenitor Cells and Aortic Aneurysm N/A
Not yet recruiting NCT01918969 - Reference Values of Circulating Endothelial Progenitor Cells N/A
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Recruiting NCT00661518 - PET/CT Imaging of Aneurysm Wall Inflammation N/A
Completed NCT00094575 - Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) Phase 4
Recruiting NCT04471909 - NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness N/A
Recruiting NCT05603520 - Phenotyping Heterogeneity and Regionality of the Aorta
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A