NCT06059053

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Jan 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2024Mar 2027

First Submitted

Initial submission to the registry

September 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 12, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

3 years

First QC Date

September 14, 2023

Last Update Submit

March 25, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Freedom from target vessel instability

    primary patency and freedom from stenosis fo the semibranch

    30 days after intervention

  • Mortality

    overall mortality rate during 30 days after intervention

    30 days after intervention

  • technical success

    Feasibility in terms of cannulation and stentgrafting of the semibranches

    During intervention

Secondary Outcomes (4)

  • Morbidity

    During follow up period (up to 3 years)

  • freedom Endoleak Type I and III

    During follow up period (up to 3 years)

  • Long term mortality

    During follow up period (up to 3 years)

  • Branch patency

    During follow up period (up to 3 years)

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Women of childbearing age
  • Patients under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muenster University Hospital

Münster, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Alexander Oberhuber, MD,PhD

    Department of Vascular and Endovascular Surgery University Hospital Münster

    STUDY CHAIR
  • Alexander Oberhuber, MD,PhD

    Department of Vascular and Endovascular Surgery University Hospital Münster

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Oberhuber, MD,PhD

CONTACT

vascular trial unit

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med. Alexander Oberhuber

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 28, 2023

Study Start

January 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations