Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
10 participants
OBSERVATIONAL
2015-01-31
2016-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Cardiac Imaging Techniques for Diagnosing Coronary Artery Disease
NCT01521468
Development and Validation of a Fast, Semi-Automated Hybrid Imaging Platform to Assess Coronary Atherosclerotic Plaque Morphology, Endothelial Shear Stress and Arterial Inflammation: A Proof of Principle Study (VALID-PET-CT)
NCT04205110
Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography
NCT03292354
Follow-up of Endovascular Aneurysm Treatment - The FEAT Trial
NCT00281411
PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
NCT05349084
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The Nellix endoprosthesis is a relatively new device used for EVAR. In present literature there is no data on the degree of physiologic inflammation following implantation of a Nellix device and the value of postoperative FDG-PET imaging to detect infection is not known. This makes the diagnosis of infection following Nellix implantation extremely difficult. This pilot is designed to determine physiologic FDG uptake following uncomplicated EVAR using the Nellix endoprosthesis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treated group
Patient group treated with Nellix Endoprosthesis.
Nellix Endoprosthesis
Implantation of Nellix
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nellix Endoprosthesis
Implantation of Nellix
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Current known inflammation or malignancy
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rijnstate Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michel Reijnen
M.D., PhD.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michel Reijnen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rijnstate Ziekenhuis
Arnhem, Gelderland, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Groot Jebbink E, van Den Ham LH, van Woudenberg BBJ, Slart RHJA, Zeebregts CJ, Rijnders TJM, Lardenoije JHP, Reijnen MMPJ. Physiological Appearance of Hybrid FDG-Positron Emission Tomography/Computed Tomography Imaging Following Uncomplicated Endovascular Aneurysm Sealing Using the Nellix Endoprosthesis. J Endovasc Ther. 2020 Jun;27(3):509-515. doi: 10.1177/1526602820913888. Epub 2020 Apr 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1093
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.