Clinical trial NCT04291430: Multi-dimensional Evaluation System for Recanalization of Symptomatic Non-acute Carotid Artery Occlusion
Official title: Establishment and Practice of Multi-dimensional Evaluation System for Recanalization of Symptomatic Non-acute Carotid Artery Occlusion
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Occlusion
Keywords: Carotid Artery Occlusion
Endovascular treatment
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population with symptomatic non-acute carotid artery occlusion confirmed by clinical and imaging assessment.

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 endovascular treatment.

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 independent risk factors for stroke recurrence in patients with carotid artery occlusion. In addition, long-term cerebral hypoperfusion and decreased cerebrovascular reactivity in patients with carotid artery occlusion may lead to cognitive impairment.

At present, the recanalization time window of anterior circulation large vessel occlusive stroke has been extended to 24 hours under certain evaluation approaches. In order to distinguish from the emergency treatment within 24 hours, patients with carotid artery occlusion over 24 hours are collectively referred as non-acute occlusion.

With the maturity of endovascular technique and the advances of interventional devices, endovascular treatment has become a hotspot of clinical research in this field. Case reports have emerged and prospective studies suggest that recanalization of chronic carotid occlusion may improve the cognitive functions. However, the clinical benefit of endovascular treatment for symptomatic non-acute carotid artery occlusion remained controversial.

The purpose of this study is to establish and verify the efficacy of a multi-dimensional evaluation system of endovascular treatment and recanalization of symptomatic non-acute carotid occlusion.

Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent form
2. Age: 18-80 years old;
3. Occlusion of the common carotid artery or internal carotid artery (mTICI=0) confirmed by DSA
4. 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
5. Occlusion over 24 hours (confirmed by imaging or according to the patient's condition change)
6. Ischemic stroke, TIA or progressive visual/cognition impairment associated with occlusion
7. Distinguishable hypoperfusion area indicated by CT perfusion (CBF decrease)

Exclusion Criteria:

1. Target vessel occlusion caused by radiotherapy, vasculitis, moyamoya disease.
2. Any history of intracranial hemorrhage (imaging confirmed or medical record confirmation, except for SWI recorded micro-bleeding) within 3 months.
3. 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)
4. Disabling before index event (mRS\>3)
5. History of serious allergy to contrast media (excluding rash), allergic to heparin, aspirin, clopidogrel, statins, metals and anesthetics, or intolerant to general anesthesia
6. Target vessel tortuous or complex vasculature which may cause procedural difficulty
7. Combined with untreated severe coronary artery stenosis or occlusion, untreated intracranial aneurysms, intracranial tumors (other than meningiomas) or any intracranial vascular malformations
8. Gastrointestinal or urinary bleeding, AMI, craniocerebral trauma, major surgery within 30 days
9. Active bleeding constitution or coagulation disease, platelet count \< 50 × 10\^9 / L
10. Uncontrolled hypertension (systolic blood pressure \> 185mmhg), GLU\<2.8 mmol/L, GLU\>18mmol/L
11. 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
12. Known to have dementia or mental illness, and unable to complete neurological and cognitive assessment
13. Expected survival time\<1 year
14. Pregnant or lactating female
15. Included in other studies and in conflict with this study
16. Other special circumstances not suitable for endovascular surgery by consideration of neuro-physician, neurosurgeon, or neurointerventional

Primary outcomes:
measure: Recurrence of ischemic stroke related to target vessels within 12 months after procedure
timeFrame: 12-month after procedure
measure: NIHSS within 12 months after procedure
timeFrame: 12-month after procedure
measure: mRS within 12 months after procedure
timeFrame: 12-month after procedure
measure: EQ-5D scale within 12 months after procedure
timeFrame: 12-month after procedure
measure: MMSE within 12 months after procedure
timeFrame: 12-month after procedure
measure: MoCA within 12 months after procedure
timeFrame: 12-month after procedure
Secondary outcomes:
measure: Technical success rate
timeFrame: Up to 24 hours after procedure
measure: Procedural success rate
timeFrame: Up to 24 hours after procedure
measure: Recurrence rate of ischemic stroke related to culprit vessel within 30 and 90 days after procedure
timeFrame: 30 days and 90days after procedure
measure: Recurrence rate of all ischemic stroke within 30 days, 90days, and 12 months after procedure
timeFrame: 30 days, 90 days and 12 months after procedure
measure: NIHSS within 30 and 90 days after procedure
timeFrame: 30 days and 90days after procedure
measure: mRS within 30 and 90 days after procedure
timeFrame: 30 days and 90days after procedure
measure: EQ-5D scale within 30 and 90 days after procedure
timeFrame: 30 days and 90days after procedure
measure: MMSE within 30 and 90 days after procedure
timeFrame: 30 days and 90days after procedure
measure: MoCA scale within 30 and 90 days after procedure
timeFrame: 30 days and 90days after procedure
measure: Improvement of cerebral blood flow in the target vessel area showed by CTP within 30 days and 12 months after procedure.
timeFrame: 30 days and 12 month after procedure
Other outcomes:
measure: Peri-procedural complications
timeFrame: Before discharge of hospitalisation
measure: Mortality caused by any stroke within 12 months after procedure
timeFrame: 12 months after procedure
measure: All-cause mortality within 12 months after procedure
timeFrame: 12 months after procedure
measure: Any type of intracranial hemorrhage 12 months after procedure
timeFrame: 12 months after procedure
measure: Symptomatic intracranial hemorrhage within 12 months after procedure
timeFrame: 12 months after procedure
measure: The incidence of in-stent restenosis /re-occlusion confirmed by DSA within 12 months after procedure
timeFrame: 12 months after procedure
measure: Bailout treatment within 12 months after procedure
timeFrame: 12 months after procedure
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Dapeng Mo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Zhongrong Miao, PhD
role: PRINCIPAL_INVESTIGATOR
References: