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ACtive Catheterization for EndovaScular TreatmentS (ACCESS)

Primary Purpose

Unruptured Intracranial Aneurysm, Arteriovenous Cerebral Malformations, Carotid Stenosis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

GECKO Active Guidewire

About this trial

This is an interventional treatment trial for Unruptured Intracranial Aneurysm focused on measuring Active catheterization / guidewire, Endovascular treatments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fondation Ophtalmologique Adolphe de Rothschild

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GECKO Active Guidewire Use

Arm Description

All patients will be treated using the GECKO guidewire to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.

Outcomes

Primary Outcome Measures

The cumulative incidence of all adverse events (serious and non-serious)

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 Outcome Measures

Number of successful GECKO guidewire placements at the target vessels

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.

Measurement of the "time"

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

Defined as the time measured from the insertion of the GECKO guidewire until the removal of the GECKO guidewire.

Overall Procedure Time

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 participants with intracranial hemorrhage

Number of participants with intracranial hemorrhage inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhage (symptomatic).

All-cause mortality.

Devices Used

All devices used will be recorded as successful or unsuccessful in conjunction with the GECKO guidewire.

Full Information

NCT ID

NCT05355259

First Posted

April 20, 2022

Last Updated

November 2, 2022

Sponsor

Basecamp Vascular

1. Study Identification

Unique Protocol Identification Number

NCT05355259

Brief Title

ACtive Catheterization for EndovaScular TreatmentS

Acronym

ACCESS

Official Title

ACCESS : ACtive Catheterization for EndovaScular TreatmentS

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

June 27, 2022 (Actual)

Primary Completion Date

August 5, 2022 (Actual)

Study Completion Date

August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Basecamp Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unruptured Intracranial Aneurysm, Arteriovenous Cerebral Malformations, Carotid Stenosis

Keywords

Active catheterization / guidewire, Endovascular treatments

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GECKO Active Guidewire Use

Arm Type

Experimental

Arm Description

All patients will be treated using the GECKO guidewire to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.

Intervention Type

Device

Intervention Name(s)

GECKO Active Guidewire

Intervention Description

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.

Primary Outcome Measure Information:

Title

The cumulative incidence of all adverse events (serious and non-serious)

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Number of successful GECKO guidewire placements at the target vessels

Description

Time Frame

During procedure

Title

Measurement of the "time"

Description

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).

Time Frame

During procedure

Title

GECKO Procedure Time

Description

Defined as the time measured from the insertion of the GECKO guidewire until the removal of the GECKO guidewire.

Time Frame

During procedure

Title

Overall Procedure Time

Description

Defined as the time measured from the insertion of the groin or radial access sheath/catheter until the removal of the access sheath

Time Frame

During procedure

Title

Number of participants with intracranial hemorrhage

Description

Number of participants with intracranial hemorrhage inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhage (symptomatic).

Time Frame

30 Days

Title

All-cause mortality.

Description

All-cause mortality.

Time Frame

30 Days

Title

Devices Used

Description

All devices used will be recorded as successful or unsuccessful in conjunction with the GECKO guidewire.

Time Frame

During procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michel Piotin, M.D.

Organizational Affiliation

Fondation Ophtalmologique Adolphe de Rothschild

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondation Ophtalmologique Adolphe de Rothschild

City

Paris

ZIP/Postal Code

75019

Country

France

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan to share IPD

Citations:

PubMed Identifier

21282505

Citation

Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ; American College of Cardiology Foundation; American Stroke Association; American Association of Neurological Surgeons; American College of Radiology; American Society of Neuroradiology; Congress of Neurological Surgeons; Society of Atherosclerosis Imaging and Prevention; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society of NeuroInterventional Surgery; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease: executive summary. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation. 2011 Jul 26;124(4):489-532. doi: 10.1161/CIR.0b013e31820d8d78. Epub 2011 Jan 31. No abstract available. Erratum In: Circulation. 2011 Jul 26;124(4):e145. Dosage error in article text.

Results Reference

background

PubMed Identifier

19339655

Citation

Lanzino G, Rabinstein AA, Brown RD Jr. Treatment of carotid artery stenosis: medical therapy, surgery, or stenting? Mayo Clin Proc. 2009 Apr;84(4):362-87; quiz 367-8. doi: 10.1016/S0025-6196(11)60546-6.

Results Reference

background

PubMed Identifier

28526977

Citation

Jansen O, Szikora I, Causin F, Bruckmann H, Lobotesis K. Standards of practice in interventional neuroradiology. Neuroradiology. 2017 Jun;59(6):541-544. doi: 10.1007/s00234-017-1837-8. Epub 2017 May 19.

Results Reference

result

PubMed Identifier

26089327

Citation

Thompson BG, Brown RD Jr, Amin-Hanjani S, Broderick JP, Cockroft KM, Connolly ES Jr, Duckwiler GR, Harris CC, Howard VJ, Johnston SC, Meyers PM, Molyneux A, Ogilvy CS, Ringer AJ, Torner J; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention; American Heart Association; American Stroke Association. Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Aug;46(8):2368-400. doi: 10.1161/STR.0000000000000070. Epub 2015 Jun 18.

Results Reference

result

PubMed Identifier

26093360

Citation

Smith TR, Cote DJ, Dasenbrock HH, Hamade YJ, Zammar SG, El Tecle NE, Batjer HH, Bendok BR. Comparison of the Efficacy and Safety of Endovascular Coiling Versus Microsurgical Clipping for Unruptured Middle Cerebral Artery Aneurysms: A Systematic Review and Meta-Analysis. World Neurosurg. 2015 Oct;84(4):942-53. doi: 10.1016/j.wneu.2015.05.073. Epub 2015 Jun 18.

Results Reference

result

PubMed Identifier

28642352

Citation

Derdeyn CP, Zipfel GJ, Albuquerque FC, Cooke DL, Feldmann E, Sheehan JP, Torner JC; American Heart Association Stroke Council. Management of Brain Arteriovenous Malformations: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Aug;48(8):e200-e224. doi: 10.1161/STR.0000000000000134. Epub 2017 Jun 22.

Results Reference

result

PubMed Identifier

22826821

Citation

Plasencia AR, Santillan A. Embolization and radiosurgery for arteriovenous malformations. Surg Neurol Int. 2012;3(Suppl 2):S90-S104. doi: 10.4103/2152-7806.95420. Epub 2012 Apr 26.

Results Reference

result

PubMed Identifier

26451020

Citation

Abbott AL, Paraskevas KI, Kakkos SK, Golledge J, Eckstein HH, Diaz-Sandoval LJ, Cao L, Fu Q, Wijeratne T, Leung TW, Montero-Baker M, Lee BC, Pircher S, Bosch M, Dennekamp M, Ringleb P. Systematic Review of Guidelines for the Management of Asymptomatic and Symptomatic Carotid Stenosis. Stroke. 2015 Nov;46(11):3288-301. doi: 10.1161/STROKEAHA.115.003390. Epub 2015 Oct 8.

Results Reference

result

Links:

URL

https://www.fda.gov/media/111329/download

Description

FDA Executive Summary General Issues: Meeting to Discuss the Evaluation of Safety and Effectiveness of Endovascular Medical Devices Intended to Treat Intracranial Aneurysms

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ACtive Catheterization for EndovaScular TreatmentS

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