Arteriovenous Cerebral Malformations, Carotid Stenosis, Unruptured Intracranial Aneurysm
Conditions
Keywords
Active catheterization / guidewire, Endovascular treatments
Brief 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.
Detailed 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.
Interventions
DEVICEGECKO Active Guidewire
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.
Sponsors
Basecamp Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective monocenter, non-randomized, open clinical investigation 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥18 years old. 2. An unruptured intracranial aneurysm, a brain arteriovenous malformation (bAVM) or dural arteriovenous fistula (DAVF) or an internal carotid artery (ICA) stenosis. 3. Subject can receive, if necessary, anti-coagulation and anti-platelet therapy according to the standard used in each study center. 4. Subject is eligible to undergo a procedure with the use of contrast media. 5. Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up. 6. Subject has given written informed consent. 7. Life expectancy \>12 months.
Exclusion criteria
1. Subject is unconscious and unable to directly provide his/her written informed consent. 2. Subject with a type 3 aortic arch will be excluded from the study. 3. Subject is or has been treated with radiation therapy to the neck or chest. 4. Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated). 5. Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFib). 6. Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke. 7. Subject is unable to complete the required follow-up. 8. 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.) 9. Subject has participated in a clinical study within the last 30 days. 10. Subject with cardiac pacemaker or defibrillator. 11. Persons under guardianship or curatorship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The cumulative incidence of all adverse events (serious and non-serious) | 30 days | The cumulative incidence of adverse events (serious and non-serious) related to the non-permanent implanted guidewire device or the procedure occurring from Day 1 to 30 days post-procedure. All Serious Adverse Events will be reported (e.g., any thromboembolic event \[intracranial embolus in the targeted vessel territory or other territory, targeted vessel dissection or dissection of any catheterized vessel\], major or minor stroke, or death within 30 days of the intervention). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the time | During procedure | Measurement of the time to navigate the distal access catheter for Primary Access into the target vessel (time from femoral or radial puncture until arrival at the target vessel). |
| GECKO Procedure Time | During procedure | Defined as the time measured from the insertion of the GECKO guidewire until the removal of the GECKO guidewire. |
| Overall Procedure Time | During procedure | Defined as the time measured from the insertion of the groin or radial access sheath/catheter until the removal of the access sheath |
| Number of successful GECKO guidewire placements at the target vessels | During procedure | Technical success is defined as successful navigation, access and correct positioning of the guidewire and the distal access catheter at the target vessel. This will be measured by the number of successful GECKO guidewire placements at the target vessels. |
| All-cause mortality. | 30 Days | All-cause mortality. |
| Devices Used | During procedure | All devices used will be recorded as successful or unsuccessful in conjunction with the GECKO guidewire. |
| Number of participants with intracranial hemorrhage | 30 Days | Number of participants with intracranial hemorrhage inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhage (symptomatic). |
Countries
France
Outcome results
None listed