Actively Recruiting

All Genders
ID05530304

Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

Led by University Hospital Muenster · Updated on 2023-09-13

30

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are monitoring the outcomes of using a triple inner branched aortic arch stentgraft in patients with aortic arch conditions such as aneurysms and dissections. This prospective, multicenter registry aims to collect new information about treatment planning and management for these aortic arch pathologies. The study observes patients treated with the triple inner branched arch stentgraft device from Terumo Aortic. The focus is on evaluating the procedure's feasibility, including cannulation and stentgrafting of the three branches, as well as tracking complications during and after the intervention. Follow-up assessments continue for up to three years to monitor long-term outcomes. Participants will be followed closely with evaluations including mortality and stroke rates 30 days after the procedure and during the three-year follow-up period. Researchers will also assess morbidity, endoleaks, patency of the stented branches, and long-term survival. Patients will need to be available for follow-up visits and provide informed consent to participate in this observational study.

CONDITIONS

Brief Title

Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Presence of aortic arch pathology
  • Treatment planned with triple inner branch from Terumo Aortic
  • Availability of the patient during the follow-up period
  • Patients informed about the study and provided written informed consent
Not Eligible

You will not qualify if you...

  • Women of childbearing age
  • Patients under 18 years

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - During intervention

Participants receive the triple inner branched arch stentgraft device as part of their treatment planning and management for aortic arch pathologies.

1 intervention visit

Post-operative Follow-up

Duration - Up to 3 years

Participants are monitored for outcomes including mortality, stroke, morbidity, endoleaks, patency of branches, and long-term safety during a follow-up period.

Regular follow-up visits during the 3-year period

Trial Site Locations

Total: 1 location

1

Muenster University Hospital

Münster, Germany

Actively Recruiting

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Research Team

A

Alexander Oberhuber, MD, PhD

V

vascular trial unit

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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