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

NCT07079956 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: NV01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Aneurysm Cerebral

Keywords

Aneurysm; Wide-neck; Fusiform; Flow Diverter

Outcome Measures

Primary Outcomes (2)

• Neurologic death, or disabling stroke

  Primary Safety Outcome

  At 12 months

• 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.

  At 12 months post-procedure

Secondary Outcomes (1)

• Performance Outcome

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

Study Arms (1)

Eligible participants will receive treatment with the TUBE Flow Diverter device

EXPERIMENTAL

the TUBE device is for the treatment of unruptured, saccular wide-neck or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 5.0 mm and located on the ICA or its branches.

Device: TUBE Flow Diverter

Interventions

TUBE Flow Diverter DEVICE

TUBE Device

Eligible participants will receive treatment with the TUBE Flow Diverter device

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants are not eligible for the study if ANY of the following criteria are present:
• 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
• Non-responders to prasugrel as determined by the P2Y12 assay ("VerifyNow" system)
• Has a known severe allergy to nickel titanium, stainless steel (304SS) tantalum, or platinum.
• Modified Rankin Score assessment is ≥ 3 at pre-procedure exam
• Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
• Subarachnoid hemorrhage occurred within 30 days prior to enrollment
• Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after enrollment date

Sponsors & Collaborators

• NVMedTech: lead
• BioMDg: collaborator
• RARAS CRO: collaborator

Study Sites (3)

Hospital Geral de Fortaleza

Fortaleza, 60150-160, Brazil

Location

Instituto Estadual do Cérebro Paulo Niemeyer

Rio de Janeiro, 20231-092, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, 71205-050, Brazil

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michel E. Frudit

  Hospital das Clínicas da Faculdade de Medicina da USP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Calderon Dr. Director Clinical and Market Affairs, Bachelors

CONTACT

307-250-2726; kcalderon@encompassf2.com

Thomas Mock, Masters

CONTACT

858-442-7887; tmock@NVMedtech.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Clinical Events Committee (CEC)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (3)