Clinical trial NCT05355259: ACtive Catheterization for EndovaScular TreatmentS
Official title: ACCESS : ACtive Catheterization for EndovaScular TreatmentS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unruptured Intracranial Aneurysm
Arteriovenous Cerebral Malformations
Carotid Stenosis
Keywords: Active catheterization / guidewire
Endovascular treatments
Lead sponsor: Basecamp Vascular
Sponsor class: INDUSTRY
First posted: 2022-05-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The cumulative incidence of all adverse events (serious and non-serious)
timeFrame: 30 days
Secondary outcomes:
measure: Number of successful GECKO guidewire placements at the target vessels
timeFrame: During procedure
measure: Measurement of the "time"
timeFrame: During procedure
measure: GECKO Procedure Time
timeFrame: During procedure
measure: Overall Procedure Time
timeFrame: During procedure
measure: Number of participants with intracranial hemorrhage
timeFrame: 30 Days
measure: All-cause mortality.
timeFrame: 30 Days
measure: Devices Used
timeFrame: During procedure
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Michel Piotin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.