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NEXUS™ Aortic Arch Stent Graft System First In Man Study

NCT02365454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-09-21

No results posted yet for this study

Summary

A multicenter, prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.

Conditions

  • Thoracic Aortic Arch Disease
  • Thoracic Aortic Aneurysm

Interventions

DEVICE

Stent Graft Placement (Nexus)

The Nexus stent graft is introduced through a groin to the diseased location at the Aortic Arch. Depending on the patients anatomy and other medical considerations the physician may decide that blood flow to the sub-clavian artery and possibly also to the left carotid artery is required to be maintained via "surgical bypass grafting", either immediately, or a few days, before the implantation. In addition to the incision for introducing the investigational stent graft, two smaller access sites are required, one at the groin on the opposite side and on into the Right Arm to the Brachial Artery. This endovascular procedure will likely require full anesthesia. The entire procedure is assisted by an angiography imaging system.

Sponsors & Collaborators

  • Endospan Ltd.

    lead INDUSTRY

Principal Investigators

  • Mario Lachat, Prof. MD · Klinic Hirslanden, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-11-30
Completion
2023-06-30

Countries

  • Czechia
  • Italy
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02365454 on ClinicalTrials.gov