ACtive Catheterization for EndovaScular TreatmentS

Carotid Stenosis Clinical Trial

— ACCESS  

Official title:

ACCESS : ACtive Catheterization for EndovaScular TreatmentS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05355259
• Other study ID #: BCV-FIH-001
• Status: Completed
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: August 5, 2022

Study information

• Verified date: November 2022
• Source: Basecamp Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Carotid Stenosis
• Intracranial Aneurysm
• Unruptured Intracranial Aneurysm

Intervention

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.

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Basecamp Vascular

Country where clinical trial is conducted

France, 

References & Publications (8)

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 — View 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. Erratum in: Circulation. 2011 Jul 26;124(4):e145. Dosage error in article text. — View 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 Ass — View Citation

Jansen O, Szikora I, Causin F, Brückmann 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. — View 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. Review. — View 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. — View 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 — View 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 Cardiovascul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	30 days
Secondary	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.	During procedure
Secondary	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).	During procedure
Secondary	GECKO Procedure Time	Defined as the time measured from the insertion of the GECKO guidewire until the removal of the GECKO guidewire.	During procedure
Secondary	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	During procedure
Secondary	Number of participants with intracranial hemorrhage	Number of participants with intracranial hemorrhage inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhage (symptomatic).	30 Days
Secondary	All-cause mortality.	All-cause mortality.	30 Days
Secondary	Devices Used	All devices used will be recorded as successful or unsuccessful in conjunction with the GECKO guidewire.	During procedure

External Links

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