NEXUS Aortic Arch Clinical Study for Aortic Conditions
This study is testing the NEXUS Aortic Stent Graft System for people with certain aortic conditions like aortic dissection or aneurysm. The system involves two stent grafts: one for the brachiocephalic artery and descending thoracic aorta, and another for the ascending aorta. Researchers want to see how safe and effective the NEXUS system is. They will measure if the device works correctly and if there are any clinical problems within 30 days. You might be able to join if you are 18 or older and have specific measurements in your aorta. The study is currently unclear on its recruitment status.
- Study design
- This is a prospective, non-randomized study involving about 110 participants at multiple centers. It is an interventional study, meaning participants will receive a treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 30 days after treatment to assess device and clinical outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
At a glance
Conditions
Where it's being run
32 sites across 23 statesWho to contact
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What this trial measures
- Device Technical Failure30 Days
* Failure to accurately deliver, track and deploy all required endovascular device components at the intended implantation site and failure to retrieve the device delivery systems without the need for unplanned additional procedures * Device occlusion * Failed exclusion of primary entry tear * Additional unanticipated surgical or interventional procedure related to the device or procedure, to prevent life-threatening or permanent disabling event.
- Clinical Failure30 Days
Subjects experiencing early mortality or at least one of the following MAEs through 30-Day of Phase 1 Procedure and 30-Day of Index Procedure: Disabling stroke, permanent paralysis/paraplegia, renal failure, aortic rupture, development of new dissections in the thoracic aorta or brachiocephalic artery.