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

NCT ID: NCT06059053

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-12

Study Completion Date

2027-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The main question it aims to answer are:

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

The participants will treated with the custom made semibranch device and enrolled in the registry if they consent. No change in treatment will be made when enrolled.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Aneurysm Endovascular Aortic Repair Stent-Graft Endoleak

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Semibranch CMD branched aortic stentgraft

bEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Univ.-Prof. Dr. med. Alexander Oberhuber

Univ.-Prof. Dr. med. Alexander Oberhuber

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander Oberhuber, MD,PhD

Role: STUDY_CHAIR

Department of Vascular and Endovascular Surgery University Hospital Münster

Alexander Oberhuber, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Vascular and Endovascular Surgery University Hospital Münster

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Muenster University Hospital

Münster, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alexander Oberhuber, MD,PhD

Role: CONTACT

+492518345781

vascular trial unit

Role: CONTACT

+492518351717

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alexander Oberhuber, MD Phd

Role: primary

+49 251 8345781

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Semibranch_Reg

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endovascular Treatment of Thoracic Aortic Disease
NCT00583817 ENROLLING_BY_INVITATION NA