Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Sweden / NCT05774938
Recruiting Observational

QoL After Complex Endovascular Aortic Repair

NCT05774938 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska University Hospital
Phase
Observational
Started
2023-02-28
Last updated
2025-04-10

Condition(s) studied

Quality of LifeAortic AneurysmAortic Aneurysm, Abdominal

Investigational drug(s) / intervention(s)

Standard Endovascular aneurysm repair (sEVAR)Complex Endovascular Aneurysm Repair (cEVAR)

Standard Endovascular aneurysm repair (sEVAR): Standard EVAR treatment with Medtronic Endurant IIs (Medtronic, Inc. - Minneapolis, Minnesota), Gore Excluder AAA (W. L. Gore \& Associates, Inc. - Newark, Delaware), Gore Excluder Conformable AAA (W. L. Gore \& Associates, Inc. - Newark, Delaware), Cook Zenith Flex (Cook Medical, Inc. - Bloomington, Indiana).

Complex Endovascular Aneurysm Repair (cEVAR): Complex EVAR treatment with custom made devices (CMD's) from Cook Medical (Cook Medical, Inc. - Bloomington, Indiana) including fenestrated or branched devices or off-the-shelf T-branch device (Cook Medical, Inc. - Bloomington, Indiana).

Study summary

The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main questions it aims to answer are:

* Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR)
* To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-/BEVAR) at one year.
* To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-/BEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years.

Participants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life.

The different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Men and women. * Any age (≥18 years) * Planned (elective) endovascular treatment by EVAR, FEVAR or BEVAR. * Patients previously treated by EVAR which are planned for an adjunct fenestrated cuff will not be included in the basic analysis, but included and analysed separately. Exclusion Criteria: * Inability to understand and/or respond to the study questionnaires that are in Swedish. * Inability to provide an informed consent for participation in the study, orally or in writing (This may be due to linguistic or cognitive limitation). * Participation in other ongoing studies concerning quality of life.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Karolinska University Hospital Stockholm Sweden Recruiting

More Karolinska University Hospital trials in Sweden

Early Mental Response - The EMRE Study Recruiting
Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB) Recruiting
Familial Risk of AAA in Sweden Active, not recruiting
Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients Active, not recruiting
PET Imaging of Solid Tumors by a Novel Tracer, 68Ga-FAPI Recruiting

Other trials for the same condition

Familial Risk of AAA in Sweden Active, not recruiting
Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm Recruiting
The Effect of Malocclusions on Oral Health Related Quality of Life Recruiting
Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer Recruiting
Functional Vision and Quality of Life in a Modern Society - With Emphasis on Myopia and Cerebral Visual Impairment Among Youth Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05774938 on ClinicalTrials.gov ↗ ← All trials in Sweden