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RecruitingNCT06374355Updated Jul 3, 2024

Semibranch Registry - Retrospective

An observational study in Aortic Aneurysm, Endovascular Aortic Repair and Stent-Graft Endoleak, sponsored by University Hospital Muenster. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by University Hospital Muenster · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The main question it aims to answer are:

  • Patency of the semibranch
  • Feasibility of the technique regarding cannulation and stentgrafting
02

Conditions studied

  • Aortic Aneurysm
  • Endovascular Aortic Repair
  • Stent-Graft Endoleak
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Eligibility criteria

  • Patient has been treated with the semibranch stentgraft
  • Patient is over 18 years old
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • DeviceSemibranch CMD branched aortic stentgraft

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

05

What researchers measure

Primary outcomes

  1. Freedom from target vessel instability

    Primary patency and freedom from stenosis of the semibranch

    Time frame: 30 days after intervention

  2. Mortality

    Overall mortality rate during 30 days after intervention

    Time frame: 30 days after intervention

  3. Technical success

    cannulation and stentgrafting ot the semibranches

    Time frame: 12 hours after intervention

Secondary outcomes

  1. Morbidity

    Access site, bowel ischemia, kidney failure, paraplegia

    Time frame: During follow up period (up to 3 years)

  2. Freedom of Endoleak type I and III

    Abscence of endoleaks arising from the semibranch

    Time frame: During follow up period (up to 3 years)

  3. Long term mortality

    Overall mortality up to 3 years

    Time frame: During follow up period (up to 3 years)

  4. Branch patency

    Primary patency of all branches

    Time frame: During follow up period (up to 3 years)

06

Study locations

1 of 1 sites recruiting
  • Muenster University Hospital
    Münster, Germany
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06374355
Lead sponsor
University Hospital Muenster
Responsible party
Univ.-Prof. Dr. med. Alexander Oberhuber (Univ.-Prof. Dr. med., University Hospital Muenster) — Principal investigator
First posted
Apr 18, 2024
Start date
Jul 2, 2024
Primary completion
Apr 2027 (estimated)
Completion
Oct 2030 (estimated)
Last update
Jul 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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