Semibranch Registry - Retrospective

Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Retrospective, Multicentre Registry

The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair.

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm; Endovascular Aortic Repair; Stent-Graft Endoleak
• Intervention / Treatment: Device: Semibranch CMD branched aortic stentgraft

Detailed Description

The main question it aims to answer are:

• Patency of the semibranch
• Feasibility of the technique regarding cannulation and stentgrafting

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Germany
  • Münster, Germany
    • Recruiting
    • Muenster University Hospital
    • Contact: Alexander Oberhuber, MD Phd; Phone Number: +49 251 8345781; Email: alexander.oberhuber@ukmuenster.de
    • Principal Investigator: Alexander Oberhuber, MD Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft

Description

• Patient has been treated with the semibranch stentgraft
• Patient is over 18 years old

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from target vessel instability	Primary patency and freedom from stenosis of the semibranch	30 days after intervention
Mortality	Overall mortality rate during 30 days after intervention	30 days after intervention
Technical success	cannulation and stentgrafting ot the semibranches	12 hours after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Access site, bowel ischemia, kidney failure, paraplegia	During follow up period (up to 3 years)
Freedom of Endoleak type I and III	Abscence of endoleaks arising from the semibranch	During follow up period (up to 3 years)
Long term mortality	Overall mortality up to 3 years	During follow up period (up to 3 years)
Branch patency	Primary patency of all branches	During follow up period (up to 3 years)

Collaborators and Investigators

• Sponsor: University Hospital Muenster

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hemorrhage; Aneurysm; Aortic Diseases; Postoperative Hemorrhage; Aortic Aneurysm; Endoleak
• Other Study ID Numbers: Semibranch_Retro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No