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

• Sponsor: University Hospital Muenster (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06059053
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 40.9
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm; Endovascular Aortic Repair; Stent-Graft Endoleak	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

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.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Mar 31, 2027

Outcome Measures

Primary Outcome Measures

1. Freedom from target vessel instability [30 days after intervention]

   primary patency and freedom from stenosis fo the semibranch

2. Mortality [30 days after intervention]

   overall mortality rate during 30 days after intervention

3. technical success [During intervention]

   Feasibility in terms of cannulation and stentgrafting of the semibranches

Secondary Outcome Measures

1. Morbidity [During follow up period (up to 3 years)]

   Access site, bowel ischemia, kidney failure, paraplegia

2. freedom Endoleak Type I and III [During follow up period (up to 3 years)]

   absence of endoleaks arising from the semibranch

3. Long term mortality [During follow up period (up to 3 years)]

   overall mortality up to 3 years

4. Branch patency [During follow up period (up to 3 years)]

   primary patency of all branches

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Muenster University Hospital	Münster		Germany

Sponsors and Collaborators

• University Hospital Muenster

Investigators

• Study Chair: Alexander Oberhuber, MD,PhD, Department of Vascular and Endovascular Surgery University Hospital Münster
• Principal Investigator: Alexander Oberhuber, MD,PhD, Department of Vascular and Endovascular Surgery University Hospital Münster

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Univ.-Prof. Dr. med. Alexander Oberhuber, Univ.-Prof. Dr. med. Alexander Oberhuber, University Hospital Muenster
• ClinicalTrials.gov Identifier: NCT06059053
• Other Study ID Numbers: Semibranch_Reg
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Endoleak

Study Results

No Results Posted as of Sep 28, 2023