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

NCT04291430 | Unknown

• 1 other identifier: KY 2019-134-03
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Occlusion

Keywords

Carotid Artery Occlusion; Endovascular treatment

Outcome Measures

Primary Outcomes (6)

• Recurrence of ischemic stroke related to target vessels within 12 months after procedure

  Including TIA, minor stroke, moderate stroke, severe stroke and fatal stroke

  12-month after procedure

• NIHSS within 12 months after procedure

  NIHSS. The NIH Stroke Scale measures several aspects of brain function, including consciousness, vision, sensation, movement, speech, and language.A certain number of points are given for each of these physical and cognitive functions during a focused neurological examination. A maximal score of 42 represents the most severe and devastating stroke. The level of stroke severity as measured by the NIH stroke scale scoring system: 0 = no stroke 1-4 = minor stroke 5-15 = moderate stroke 15-20 = moderate/severe stroke 21-42 = severe stroke

  12-month after procedure

• mRS within 12 months after procedure

  The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. (Score Description: 0---No symptoms at all. 1---No significant disability despite symptoms; able to carry out all usual duties and activities. 2---Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance. 3---Moderate disability; requiring some help, but able to walk without assistance. 4--- Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5---Severe disability; bedridden, incontinent and requiring constant nursing care and attention. 6---Dead.

  12-month after procedure

• EQ-5D scale within 12 months after procedure

  The EQ-5D essentially consists of two pages: the EQ-5D descriptive system and the EQ-5D visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine'( score as 100) and 'The worst health you can imagine' (score as 0). This information can be used as a quantitative measure of health outcome as judged by the individual respondents.

  12-month after procedure

• MMSE within 12 months after procedure

  The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.

  12-month after procedure

• MoCA within 12 months after procedure

  The Montreal Cognitive Assessment (MoCA) is a widely used screening assessment for detecting cognitive impairment.The MoCA test is a one-page 30-point test administered in approximately 10 minutes. The MoCA assesses: Short term memory/ Visuospatial abilities/ Executive functions/ Attention, concentration and working memory/ Language/ Orientation to time and place.

  12-month after procedure

Secondary Outcomes (10)

• Technical success rate

  Up to 24 hours after procedure

• Procedural success rate

  Up to 24 hours after procedure

• Recurrence rate of ischemic stroke related to culprit vessel within 30 and 90 days after procedure

  30 days and 90days after procedure

• Recurrence rate of all ischemic stroke within 30 days, 90days, and 12 months after procedure

  30 days, 90 days and 12 months after procedure

• NIHSS within 30 and 90 days after procedure

  30 days and 90days after procedure

Other Outcomes (7)

• Peri-procedural complications

  Before discharge of hospitalisation

• Mortality caused by any stroke within 12 months after procedure

  12 months after procedure

• All-cause mortality within 12 months after procedure

  12 months after procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population with symptomatic non-acute carotid artery occlusion confirmed by clinical and imaging assessment.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

Study Officials

• Dapeng Mo, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Zhongrong Miao, PhD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dapeng Mo, PhD

CONTACT

+86 13691419036; modapeng1971@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: December 25, 2019
• Primary Completion: December 24, 2022
• Study Completion: May 31, 2023
• Last Updated: July 28, 2020

Record last verified: 2020-02

Locations

CN (1)