Status:
UNKNOWN
Multi-dimensional Evaluation System for Recanalization of Symptomatic Non-acute Carotid Artery Occlusion
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Carotid Artery Occlusion
Eligibility:
All Genders
18-80 years
Brief Summary
This is a multi-center, prospective, exploratory, observational, registration study on patients with symptomatic non-acute carotid artery occlusion to initially evaluate the safety and efficacy of end...
Detailed Description
Although patients with symptomatic carotid occlusion were primarily treated with medication, the risk of 2-year stroke recurrence was as high as 22.7%. Ipsilateral stroke and hemodynamic decline are i...
Eligibility Criteria
Inclusion
- Sign the informed consent form
- Age: 18-80 years old;
- Occlusion of the common carotid artery or internal carotid artery (mTICI=0) confirmed by DSA
- The origin of occlusive segment is from the common carotid artery or the initial segment of the internal carotid artery to the petrous segment and above, and does not exceed the bifurcation of the internal carotid artery (C7 segment). The distal occluded vessels, including the middle cerebral artery, have no severe stenosis or occlusion confirmed by angiography
- Occlusion over 24 hours (confirmed by imaging or according to the patient's condition change)
- Ischemic stroke, TIA or progressive visual/cognition impairment associated with occlusion
- Distinguishable hypoperfusion area indicated by CT perfusion (CBF decrease)
Exclusion
- Target vessel occlusion caused by radiotherapy, vasculitis, moyamoya disease.
- Any history of intracranial hemorrhage (imaging confirmed or medical record confirmation, except for SWI recorded micro-bleeding) within 3 months.
- Large core infarction history or index stroke caused by large core infarction (infarct volume \>70ml, or exceeding the MCA territory \>1/3, or middle cerebral structural shifting)
- Disabling before index event (mRS\>3)
- History of serious allergy to contrast media (excluding rash), allergic to heparin, aspirin, clopidogrel, statins, metals and anesthetics, or intolerant to general anesthesia
- Target vessel tortuous or complex vasculature which may cause procedural difficulty
- Combined with untreated severe coronary artery stenosis or occlusion, untreated intracranial aneurysms, intracranial tumors (other than meningiomas) or any intracranial vascular malformations
- Gastrointestinal or urinary bleeding, AMI, craniocerebral trauma, major surgery within 30 days
- Active bleeding constitution or coagulation disease, platelet count \< 50 × 10\^9 / L
- Uncontrolled hypertension (systolic blood pressure \> 185mmhg), GLU\<2.8 mmol/L, GLU\>18mmol/L
- Severe cardiac insufficiency, severe liver injury (AST or ALT more than 3 times of normal value), severe renal insufficiency (creatinine \> 177 μ mol / L)， and other late-stage disease
- Known to have dementia or mental illness, and unable to complete neurological and cognitive assessment
- Expected survival time\<1 year
- Pregnant or lactating female
- Included in other studies and in conflict with this study
- Other special circumstances not suitable for endovascular surgery by consideration of neuro-physician, neurosurgeon, or neurointerventional
Key Trial Info
Start Date :
December 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04291430
Start Date
December 25 2019
End Date
May 31 2023
Last Update
July 28 2020
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100010