ACtive Catheterization for EndovaScular TreatmentS

NCT05355259 | Completed DMC

• 1 other identifier: BCV-FIH-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Unruptured Intracranial Aneurysm; Arteriovenous Cerebral Malformations; Carotid Stenosis

Keywords

Active catheterization / guidewire; Endovascular treatments

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of successful GECKO guidewire placements at the target vessels

  During procedure

• Measurement of the "time"

  During procedure

• GECKO Procedure Time

  During procedure

• Overall Procedure Time

  During procedure

• Number of participants with intracranial hemorrhage

  30 Days

Study Arms (1)

GECKO Active Guidewire Use

EXPERIMENTAL

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

Interventions

GECKO Active Guidewire DEVICE

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.

GECKO Active Guidewire Use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 has participated in a clinical study within the last 30 days.
• Subject with cardiac pacemaker or defibrillator.
• Persons under guardianship or curatorship.

Sponsors & Collaborators

• Basecamp Vascular: lead

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Related Publications (8)

• 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.

  PMID: 21282505 BACKGROUND

• 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.

  PMID: 19339655 BACKGROUND

• 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.

  PMID: 28526977 RESULT

• 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.

  PMID: 26089327 RESULT

• 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.

  PMID: 26093360 RESULT

• 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.

  PMID: 28642352 RESULT

• 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.

  PMID: 22826821 RESULT

• 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.

  PMID: 26451020 RESULT

Related Links

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

MeSH Terms

Conditions

Intracranial Arteriovenous Malformations; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Diseases; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carotid Artery Diseases; Arterial Occlusive Diseases

Study Officials

• Michel Piotin, M.D.

  Fondation Ophtalmologique Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 2, 2022
• Study Start: June 27, 2022
• Primary Completion: August 5, 2022
• Study Completion: August 5, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)