Unruptured intracranial aneurysm Unruptured intracranial aneurysm, Cerebral aneurysm, Endovascular therapy, Transradial approach, Transfemoral approach
Conditions
Interventions
Endovascular treatment of unruptured intracranial aneurysm via
- transradial approach using the RIST radial access guiding catheter system, versus
- standard transfemoral approach using a conventional
D057510
Transradial approach, Transfemoral approach, RIST guiding catheter, Endovascular coiling, Flow diverter
Sponsors
Tsuruta Wataro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 20 years or older at registration. 2) Patients scheduled to undergo endovascular treatment (intra-aneurysmal embolization or flow-diverting stent placement) for unruptured cerebral aneurysms. 3) Patients deemed suitable for either the transradial approach (TRA) or the transfemoral approach (TFA) by the operator. 4) Patients with a radial artery diameter of >/= 2.0 mm at the planned puncture site AND a femoral artery diameter of >/= 2.0 mm at the planned puncture site (measured by ultrasonography, angiography, or CTA). 5) Patients for whom written informed consent for participation in this study has been obtained from the patient or a legally authorized representative.
Exclusion criteria
Exclusion criteria: 1) Patients deemed high risk for either TRA or TFA due to anatomical findings in the access route, including any of the following: - Loop formation in the radial-to-brachial artery segment, brachioradial artery configuration, or a narrow segment (<2.0 mm) at the planned radial puncture site. - A narrow segment (<2.0 mm) in the femoral artery at/along the planned access route. - Presence of an aortic aneurysm or aortic dissection that impedes access. - Prior stent placement or graft replacement considered to compromise the access route. - Severe tortuosity of the internal carotid artery or extracranial vertebral artery (internal carotid artery: coiling or kinking; extracranial vertebral artery: coiling, kinking, or two or more sharp bends). - A narrow segment (<2.0 mm) in the common carotid artery, extracranial internal carotid artery, or extracranial vertebral artery. 2) Patients with an expected life expectancy of 90 days or less. 3) Patients who do not wish to allow the use or provision of their clinical information for this study. 4) Patients for whom the treating physician determines that participation in the study may compromise the subject's health or the scientific validity of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate. Treatment completion is defined as successful placement of embolization devices in all target aneurysms and/or placement of a flow-diverting stent in the parent vessel as intended. When multiple aneurysms are treated, the targets must be accessible without changing the vessel in which the guiding system is positioned. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1.Successful placement of a sheath/guiding sheath in the access vessel. 2.Successful placement of the guiding system in the target vessel. 3.Procedure time. 4.Fluoroscopy dose. 5.Patient comfort, assessed by the need for analgesic or sedative medication for puncture-site pain or discomfort related to immobilization. Safety: 1.Any intracranial hemorrhage within 24 hours after the procedure. 2.Symptomatic intracranial hemorrhage within 24 hours after the procedure. 3.Any cerebral infarction within 24 hours after the procedure. 4.Symptomatic cerebral infarction within 24 hours after the procedure. 5.Hemorrhagic access-site complications (pseudoaneurysm, bleeding requiring transfusion). 6.Access-vessel occlusion within 90 days (after hemostasis, at discharge, at 30 days, and at 90 days). 7.All-cause mortality and modified Rankin Scale (mRS) within 90 days. Exploratory endpoints: 1.Factors associated with treatment completion with the transradial approach (TRA). 2.Prespecified subgroup analysis: factors associated with TRA treatment completion among cases treated via a left internal carotid artery (ICA) approach. | — |
Contacts
Public ContactWataro Tsuruta
Department of Endovascular Neurosurgery, Toranomon Hospital
Outcome results
None listed