NCT06374355

Brief Summary

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.

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
53mo left

Started Jul 2024

Longer than P75 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 Progress30%
Jul 2024Oct 2030

First Submitted

Initial submission to the registry

April 4, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

July 2, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2.7 years

First QC Date

April 4, 2024

Last Update Submit

July 2, 2024

Conditions

Aortic AneurysmEndovascular Aortic RepairStent-Graft Endoleak

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Morbidity

    During follow up period (up to 3 years)

  • Freedom of 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

Semibranch CMD branched aortic stentgraftDEVICE

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Muenster University Hospital

Münster, Germany

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr. med.

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 18, 2024

Study Start

July 2, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2030

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

DE(1)