Health TrialsbyHealthPanel

Study to Evaluate the TUBE Device Ability to Treat Unruptured, Wide-neck or Fusiform Aneurysms

ConditionAneurysm Cerebral
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22-80
SponsorNVMedTech

About this trial

To assess the safety and performance of the TUBE device in the endovascular treatment of unruptured, wide-neck or fusiform intracranial aneurysms located on the internal carotid artery (ICA) or its branches

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Is located on the internal carotid artery or its branch-es.

Has a neck ≥ 4 mm, dome to neck ratio < 2.0, or no discernible neck

Aneurysm diameter ≤ 35 mm (saccular or fusiform configuration)

Has a parent vessel diameter ≥ 2.0 mm and ≤ 5.0 mm at both the proximal and distal segments where the implant will be placed.

Disqualifiers

Has an extradural aneurysm

Has a target aneurysm in the posterior circulation

Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from study)

Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation

Trial design

Design model

Single group

Treatments tested in this trial

  • TUBE Flow Diverter

    Device

    TUBE Device

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Eligible participants will receive treatment with the TUBE Flow Diverter deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Neurologic death, or disabling stroke

Primary Safety Outcome

Time frame
At 12 months
2

Primary Performance Outcome

The proportion of participants with composite of 100% occlusion (Raymond-Roy Classification 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (\> 50% stenosis) on digital subtraction angiography (DSA) images.

Time frame
At 12 months post-procedure

Secondary outcomes

1

Performance Outcome

The proportion of participants with composite of 100% occlusion (Raymond-Roy Classification 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (\> 50% stenosis) and with no retreatment of the target aneurysm.

Time frame
1 month, 3 months, and 6 months post-procedure respectively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NVMedTech

Lead sponsor

BioMDg

Collaborator

RARAS CRO

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: