Actively Recruiting
Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
Led by University Hospital Muenster · Updated on 2024-03-26
100
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of a semibranch device in branched endovascular aortic repair for patients with pararenal or thoracoabdominal aortic conditions. The study is observational and seeks to answer key questions about the device's patency and the feasibility of the technique involving cannulation and stent grafting. It focuses on safety and technical success without altering the standard treatment for participants. Participants will be treated with a custom-made semibranch abdominal aortic multibranch stent graft device as part of their endovascular repair. The study does not change participants' treatments but enrolls those who consent to collect data on their outcomes. The registry will monitor the device’s performance and related clinical results during and after the procedure. During the study, researchers will track several outcomes including freedom from target vessel instability, mortality within 30 days of intervention, and technical success during the procedure. They will also monitor longer-term results such as morbidity, endoleak occurrence, branch patency, and mortality up to three years after treatment. Participants will be followed over time to assess these measures and provide data on the safety and function of the semibranch device.
CONDITIONS
Brief Title
Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Presence of pararenal or thoracoabdominal aortic pathology
- Treatment planned with a semibranch device branch from Artivion
- Availability of the patient during the follow-up period
- Patient informed about the study and providing written consent
You will not qualify if you...
- Women of childbearing age
- Patients under 18 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Duration of the intervention procedure
Participants undergo treatment with a custom made semibranch branched aortic stentgraft device as planned.
1 visit (in-person) during the intervention
Duration - Up to 3 years
Participants are monitored for up to 3 years to assess morbidity, branch patency, freedom from endoleak, and long-term mortality.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Muenster University Hospital
Münster, Germany
Actively Recruiting
Research Team
A
Alexander Oberhuber, MD,PhD
V
vascular trial unit
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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