Not Yet RecruitingPhase 1

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

Brazil20 participantsStarted 2025-10

Plain-language summary

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

Who can participate

Age range22 Years – 80 Years

SexALL

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Inclusion criteria

✓. Has a single unruptured target intracranial aneurysm (IA) with the following characteristics:
✓. 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.
✓. Has multiple increased risk factors for intracranial aneurysm rupture, including but not limited to, aneurysm morphology, smoking, hypertension, diabetes, age, prior and/or family history of aneurysm rupture, and/or history of subarachnoid hemorrhage that may result in a benefit risk profile of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the patient's expected lifetime if left untreated.
✓. The patient is able and willing to provide written in-formed consent.

Exclusion criteria

✕. 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
✕. Target aneurysm is unsuitable for flow diverter treatment
✕. Has vessel characteristics, such as severe tortuosity (cICA Type IV), stenosis (\>70%), or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
✕. Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
✕. Has a medical contraindication to study or procedure related antiplatelet medications (aspirin, clopidogrel/ Plavix, prasugrel, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye

What they're measuring

Neurologic death, or disabling stroke

Timeframe: At 12 months

Primary Performance Outcome

Timeframe: At 12 months post-procedure

Trial details

NCT IDNCT07079956

SponsorNVMedTech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

Kathleen Calderon Dr. Director Clinical and Market Affairs, Bachelors

307-250-2726 kcalderon@encompassf2.com

View on ClinicalTrials.gov More Aneurysm Cerebral trials