ACtive Catheterization for EndovaScular TreatmentS (ACCESS)

November 2, 2022 updated by: Basecamp Vascular

ACCESS : ACtive Catheterization for EndovaScular TreatmentS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GECKO Active Guidewire Use
All patients will be treated using the GECKO guidewire to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.
Device: GECKO 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cumulative incidence of all adverse events (serious and non-serious)
Time Frame: 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).
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of successful GECKO guidewire placements at the target vessels
Time Frame: 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.
During procedure
Measurement of the "time"
Time Frame: 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).
During procedure
GECKO Procedure Time
Time Frame: During procedure
Defined as the time measured from the insertion of the GECKO guidewire until the removal of the GECKO guidewire.
During procedure
Overall Procedure Time
Time Frame: 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
During procedure
Number of participants with intracranial hemorrhage
Time Frame: 30 Days
Number of participants with intracranial hemorrhage inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhage (symptomatic).
30 Days
All-cause mortality.
Time Frame: 30 Days
All-cause mortality.
30 Days
Devices Used
Time Frame: During procedure
All devices used will be recorded as successful or unsuccessful in conjunction with the GECKO guidewire.
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basecamp Vascular

Investigators

  • Principal Investigator: Michel Piotin, M.D., Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2022

Primary Completion (Actual)

August 5, 2022

Study Completion (Actual)

August 5, 2022

Study Registration Dates

First Submitted

April 20, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCV-FIH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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