Carotid Stenosis Clinical Trial
— ACCESSOfficial title:
ACCESS : ACtive Catheterization for EndovaScular TreatmentS
Verified date | November 2022 |
Source | Basecamp Vascular |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Fondation Ophtalmologique Adolphe de Rothschild | Paris |
Lead Sponsor | Collaborator |
---|---|
Basecamp Vascular |
France,
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
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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 |
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