Multi-dimensional Evaluation System for Recanalization of Symptomatic Non-acute Carotid Artery Occlusion

NCT ID: NCT04291430

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-25
• Study Completion Date: 2023-05-31

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.

Conditions

Carotid Artery Occlusion

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dapeng Mo, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Zhongrong Miao, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dapeng Mo, PhD

Role: CONTACT

modapeng1971@163.com

+86 13691419036

Facility Contacts

Dapeng Mo, PhD

Role: primary

modapeng1971@163.com

+86 13691419036‬

Other Identifiers

KY 2019-134-03

Identifier Type: -

Identifier Source: org_study_id