Evaluating a new device for aortic repair
Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
University Hospital Muenster · NCT06059053
This study is testing a new custom-made device for repairing certain aortic problems to see if it works well and is easy to use for patients needing this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Muenster (other) |
| Locations | 1 site (Münster) |
| Trial ID | NCT06059053 on ClinicalTrials.gov |
What this trial studies
This registry aims to assess the effectiveness of a custom-made semibranch device in branched endovascular aortic repair for patients with pararenal and thoracoabdominal aortic pathologies. It will evaluate the patency of the semibranch and the feasibility of the technique concerning cannulation and stent grafting. Participants will be treated with the semibranch device and enrolled in the registry upon consent, with no changes to their treatment plan during the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pararenal or thoracoabdominal aortic pathologies who are scheduled for treatment with the semibranch device.
Not a fit: Patients under 18 years old and women of childbearing age will not benefit from this study.
Why it matters
Potential benefit: If successful, this could improve outcomes for patients undergoing endovascular aortic repair.
How similar studies have performed: While this approach is novel, similar studies in endovascular aortic repair have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Informing patients about the study and providing written informed consent Exclusion Criteria: * Women of childbearing age * Patients under 18 years
Where this trial is running
Münster
- Muenster University Hospital — Münster, Germany (RECRUITING)
Study contacts
- Principal investigator: Alexander Oberhuber, MD,PhD — Department of Vascular and Endovascular Surgery University Hospital Münster
- Study coordinator: Alexander Oberhuber, MD,PhD
- Email: alexander.oberhuber@ukmuenster.de
- Phone: +492518345781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aortic Aneurysm, Endovascular Aortic Repair, Stent-Graft Endoleak