ACtive Catheterization for EndovaScular TreatmentS (ACCESS)

  • STATUS
    Recruiting
  • End date
    Jun 28, 2023
  • participants needed
    10
  • sponsor
    Basecamp Vascular
Updated on 4 October 2022
stenosis

Summary

The objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.

Description

The Basecamp Vascular trial is a prospective monocenter, non-randomized, open clinical investigation of their controllable directional GECKO guidewire which has not yet received the CE mark. The GECKO active guidewire is a sterile, single-use device to be used by interventional neuroradiologists (INR) to position a distal access catheter (DAC). The device is a system composed of a deflector (the guide) and a handle. The handle contains the battery and integrated electronics. The device can be activated using buttons on the handle. When the user presses a button, a current is transmitted along the guide to its end: this allows the guide to bend (two possible curves). The end of the device can then take an "S" shape. In INR, the placement of a DAC (at the cervical level) is the first step of an endovascular intervention (Primary Access). This is followed by the treatment phase of the vascular pathology with other medical devices (example: embolization, angioplasty). The GECKO active guide is a system that facilitates endovascular navigation and allows the positioning of the DAC via vascular access (femoral or radial artery). The GECKO device is intended to introduce devices used for treatment, at a desired anatomical location (cervical carotid artery, for example) in the central circulatory system. The GECKO guidewire itself is not meant to perform a treatment but is used to set the primary access that will allow performance of the treatments.

Details
Condition Unruptured Intracranial Aneurysm, Arteriovenous Cerebral Malformations, Carotid Stenosis
Treatment GECKO Active Guidewire
Clinical Study IdentifierNCT05355259
SponsorBasecamp Vascular
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female ≥18 years old
An unruptured intracranial aneurysm, a brain arteriovenous malformation (bAVM) or dural arteriovenous fistula (DAVF) or an internal carotid artery (ICA) stenosis
Subject can receive, if necessary, anti-coagulation and anti-platelet therapy according to the standard used in each study center
Subject is eligible to undergo a procedure with the use of contrast media
Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up
Subject has given written informed consent
Life expectancy >12 months

Exclusion Criteria

Subject is unconscious and unable to directly provide his/her written informed consent
Subject with a type 3 aortic arch will be excluded from the study
Subject is or has been treated with radiation therapy to the neck or chest
Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated)
Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFib)
Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke
Subject is unable to complete the required follow-up
Subject is pregnant or breastfeeding. (Females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)
Subject has participated in a clinical study within the last 30 days
Subject with cardiac pacemaker or defibrillator
Persons under guardianship or curatorship
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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