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Carotid Artery OcclusionNCT04291430

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

An observational study of Carotid Artery Occlusion, run by Beijing Tiantan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carotid Artery Occlusion
How many people
300 participants
Where
1 siteChina
Study dates
25 Dec 2019to 31 May 2023
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Dapeng Mo, PhD contact

+86 13691419036

modapeng1971@163.com

China1 site, 1 recruiting

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100010

    Dapeng Mo, PhD, +86 13691419036‬, modapeng1971@163.com

    Recruiting

Other trials in China

About this study

Official title: Establishment and Practice of Multi-dimensional Evaluation System for Recanalization of Symptomatic Non-acute Carotid Artery Occlusion

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.

Read the 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.

Keywords
Carotid Artery Occlusion, Endovascular treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 12-month after procedure

  2. 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

    Measured: 12-month after procedure

  3. 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.

    Measured: 12-month after procedure

  4. 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.

    Measured: 12-month after procedure

  5. 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.

    Measured: 12-month after procedure

  6. 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.

    Measured: 12-month after procedure

Secondary outcomes (10)

  1. Technical success rate

    Defined as the target vessel residual stenosis less than 50% and mTICI grade ≥ 2b

    Measured: Up to 24 hours after procedure

  2. Procedural success rate

    Defines as the residual stenosis of the target vessel is less than 50%, and the TICI grade is ≥ 2b, and free of peri-procedural complications.

    Measured: Up to 24 hours after procedure

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

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

    Measured: 30 days and 90days after procedure

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

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

    Measured: 30 days, 90 days and 12 months after procedure

  5. NIHSS within 30 and 90 days 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

    Measured: 30 days and 90days after procedure

  6. mRS within 30 and 90 days 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.

    Measured: 30 days and 90days after procedure

  7. EQ-5D scale within 30 and 90 days 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.

    Measured: 30 days and 90days after procedure

  8. MMSE within 30 and 90 days 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.

    Measured: 30 days and 90days after procedure

  9. MoCA scale within 30 and 90 days 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.

    Measured: 30 days and 90days after procedure

  10. Improvement of cerebral blood flow in the target vessel area showed by CTP within 30 days and 12 months after procedure.

    Quantitative analysis by e-Stroke software

    Measured: 30 days and 12 month after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start25 Dec 2019
  3. Primary completion24 Dec 2022 (estimated)
  4. Study completion31 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291430
Sponsor's protocol ID
KY 2019-134-03
Status last verified
Feb 2020
First submitted
27 Feb 2020
Last updated
28 Jul 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Carotid Artery Occlusion, run by Beijing Tiantan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dapeng Mo, PhD (+86 13691419036, modapeng1971@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of ischemic stroke related to target vessels within 12 months after procedure (time frame: 12-month after procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04291430.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

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