Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Muenster
About this trial
The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Presence of pararenal or thoracoabdominal aortic pathology
Treatment planned a semibranch device branch from Artivion
Availability of the patients during the follow up period
Disqualifiers
Women of childbearing age
Patients under 18 years
Trial population
Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Semibranch CMD branched aortic stentgraft
DevicebEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Freedom from target vessel instability
primary patency and freedom from stenosis fo the semibranch
Time frame
30 days after intervention2
Mortality
overall mortality rate during 30 days after intervention
Time frame
30 days after intervention3
technical success
Feasibility in terms of cannulation and stentgrafting of the semibranches
Time frame
During interventionSecondary outcomes
1
Morbidity
Access site, bowel ischemia, kidney failure, paraplegia
Time frame
During follow up period (up to 3 years)2
freedom Endoleak Type I and III
absence of endoleaks arising from the semibranch
Time frame
During follow up period (up to 3 years)3
Long term mortality
overall mortality up to 3 years
Time frame
During follow up period (up to 3 years)4
Branch patency
primary patency of all branches
Time frame
During follow up period (up to 3 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov