Intracranial Atherosclerotic Stenosis (ICAS)CRTICAS-2NCT06740513
The New Clinical Registration Trial of Interventional Treatment for Patients with Symptomatic Intracranial Artery Stenosis
An observational study of Intracranial Atherosclerotic Stenosis (ICAS) and Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Background: Intracranial atherosclerotic stenosis (ICAS) is a major etiology of stroke worldwide, especially in East and South Asia, accounting for up to 50% of all ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Atherosclerotic Stenosis (ICAS), Stroke
- What is being tested?
- Endovascular Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All symptomatic intracranial atherosclerotic stenosis (sICAS) patients receiving endovascular treatment.
Who may be able to join
- (1)18-80 years old; (2)Received endovascular therapy during hospitalization; (3) Intracranial arterial stenosis related to the following non-atherosclerotic factors will be not be considered: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus; (4) Symptomatic intracranial stenosis: presented with transient ischemic stroke (TIA) or stroke within the past 12 months attributed to 70%-99% stenosis of a major intracranial artery (ICA, MCA [M1], vertebral artery, or basilar artery [BA]); (5) Degree of stenosis: 70%-99%; stenosis degree must be consistent with the criteria of endovascular treatment ; (6) No massive cerebral infarction (>1/2 MCA territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan; (7) Patient is willing and able to return for all follow-up visits required by the protocol; (8) Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Who cannot join
- Patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors;
- History of life-threatening allergy to contrast medium. If not life threatening and can be effectively pre-treated, patient can be enrolled at physicians' discretion;
- Active bleeding diathesis or coagulopathy; active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count <125,000, hematocrit <30, Hgb <10g/dL, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia that increases the risk of bleeding, uncontrolled severe hypertension (systolic BP>180mmHg or diastolic BP>115mmHg), severe liver impairment (AST or ALT >3 times normal, cirrhosis), creatinine >265.2 mmol/L (unless on dialysis).
- Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment;
- Severe dementia or psychiatric problems that prevent the patients from following an outpatient program reliably;
- Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100070
Liqun Jiao, MD, 86-10-83198899 ext 8836, jiaoliqun@gmail.com
About this study
Background:
Intracranial atherosclerotic stenosis (ICAS) is a major etiology of stroke worldwide, especially in East and South Asia, accounting for up to 50% of all ischemic stroke. Previous three randomized clinical trials did not demonstrate the superiority of intracranial stenting over aggressive medical management for symptomatic intracranial atherosclerotic stenosis (sICAS). The SAMMPRIS and VISSIT trials demonstrated that aggressive medical management was superior to self-expanding stenting and balloon-expanding stenting for sICAS. The CASSISS trial showed no significant difference in the risk of stroke or death between self-expanding stenting and aggressive medical management for sICAS. But recent BASIS trial demonstrated that balloon angioplasty plus aggressive medical management, compared with aggressive medical management alone, lowered the risk of a composite outcome.
Read more
CRTICAS was a prospective, real-world registry with 26 participating centres. It demonstrated a lower complication rate in treating patients with symptomatic ICAS with endovascular therapy in a real-world context, compared with the preceding RCTs. Uneven development in endovascular technology, institutional experience and patient selection in different volumes of centres may have an impact on overall safety of this treatment. The patients were screened from December 2013 to December 2015, which was almost 10 years ago. In consideration of the development of imaging evaluation and interventional devices, the CRTICAS-2 aims to figure out the effect and safety of endovascular treatment plus medical management for sICAS patients nowadays.
Methods:
As a multicenter and prospective cohort study, it starts in December 2024, the observation is scheduled to be completed by December 2028, with a total of at least 1000 sICAS patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 12 months after the occurrence of symptomatic stroke.
Study Design:
In this study, an observational cohort will be set up. The primary outcome is the effect of endovascular treatment, which is subject to assessment using the total mortality and symptomatic stroke. The second outcome is the safety of endovascular treatment, with the postoperative ischemic complication. Based on the observation of the characteristics and outcome of sICAS patients, the ischemic events after surgery will be further addressed, and the function assessment system for operated sICAS patients will be established. We will detailedly collect the clinical data of all patients registered for the study includes medical record data; imaging examination; laboratory examination; hemodynamic evaluation and cognitive function evaluation. The imaging examination includes Magnetic Resonance Imaging(MRI), High-Resolution Magnetic Resonance Imaging(HRMRI), Computed Tomography Angiography(CTA), Magnetoencephalography (MEG) , Ultrasound and so on. The hemodynamic evaluation includes Optical CoherenceTomography (OCT), noninvasive FFR estimated from Phase Contrast Magnetic Resonance Angiography (PC-MRA) and so on. The cognitive function evaluation includes cognitive domains of verbal episodic memory, semantic verbal fluency, confrontation naming, mental processing speed-attention, executive function-cognitive flexibility and so on.
Objective:
To observe the effect of endovascular treatment plus medical therapy in patients with symptomatic intracranial atherosclerotic stenosis.
- Being tested
- Endovascular Treatment
- Keywords
- Intracranial atherosclerotic stenosis, clinical registration trial, interventional treatment, Medical Therapy plus Stent/Balloon Angioplasty, Endovascular Treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TreatmentProcedure or surgery
Medical Therapy plus Stent/Balloon Angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Treatment Group | all the participants in this group will be performed with endovascular treatment Receives: Procedure: Endovascular Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of stroke or all-cause mortality
Stroke includes ischemic and hemorrhagic stroke, and is confirmed by postoperative imaging. Death defined as a mRS score of 6.
Measured: Within 30 days after surgery
Stroke in the qualifying artery territory
Including ischemic and hemorrhagic stroke, and confirmed by postoperative imaging.
Measured: After surgery 3 months, 6 months and 1 year.
Secondary outcomes (8)
Changes of the National Institutes of Health Stroke Scale (NIHSS) score
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit)
Measured: After surgery 30 days, 3 months, 6 months, 1 year, 2 years and 3 years.
Changes in Modified Rankin Scale(mRS)
The mRS score range from 0 (no disability) to 6 (death)
Measured: After surgery 3 months, 6 months and 1 year, 2 years and 3 years.
Stroke in the qualifying artery territory
Including ischemic and hemorrhagic stroke, and confirmed by postoperative imaging.
Measured: After surgery 2 years and 3 years.
All-cause mortality
Death defined as a mRS score of 6
Measured: After surgery 1 year, 2 years and 3 years.
Cognitive assessment score
The cognitive function evaluation includes cognitive domains of verbal episodic memory, semantic verbal fluency, confrontation naming, mental processing speed-attention, executive function-cognitive flexibility and so on.
Measured: After surgery 3 months, 6 months and 1 year, 2 years and 3 years.
Serious Adverse Event
Myocardial infarction, epilepsy and any adverse events requiring unexpected surgical treatment.
Measured: After surgery 30days, 3 months, 6 months and 1 year, 2 years and 3 years.
EQ-5D-5L
The EQ-5D 5-Levels (EQ-5D-5L) range from 5 (no problems) to 25 (extreme problems), which deceased patients have a utility of 0.
Measured: After surgery 1 year, 2 years and 3 years.
Self-Rating Depression Scale(SDS) or Hamilton Depression Scale(HDRS)
SDS range from 25 (Normal) to 100 (Very Severe Depression); HDRS range from 0 (Normal) to 42 (Very Severe Depression).
Measured: After surgery 1 year, 2 years and 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Atherosclerotic Stenosis (ICAS)Studies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740513
- Sponsor's protocol ID
- CRTICAS-2
- Acronym
- CRTICAS-2
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The New Clinical Registration Trial of Interventional Treatment for Patients with Symptomatic Intracranial Artery Stenosis
- ClinicalTrials.gov ID
- NCT06740513
- Acronym / sponsor ID
- CRTICAS-2 / CRTICAS-2
- Keywords
- Intracranial atherosclerotic stenosis, clinical registration trial, interventional treatment, Medical Therapy plus Stent/Balloon Angioplasty, Endovascular Treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Intracranial atherosclerotic stenosis (ICAS) is a major etiology of stroke worldwide, especially in East and South Asia, accounting for up to 50% of all ischemic stroke. Previous three randomized clinical trials did not demonstrate the superiority of intracranial stenting over aggressive medical management for symptomatic intracranial atherosclerotic stenosis (sICAS). The SAMMPRIS and VISSIT trials demonstrated that aggressive medical management was superior to self-expanding stenting and balloon-expanding stenting for sICAS. The CASSISS trial showed no significant difference in the risk of stroke or death between self-expanding stenting and aggressive medical management for sICAS. But recent BASIS trial demonstrated that balloon angioplasty plus aggressive medical management, compared with aggressive medical management alone, lowered the risk of a composite outcome.
CRTICAS was a prospective, real-world registry with 26 participating centres. It demonstrated a lower complication rate in treating patients with symptomatic ICAS with endovascular therapy in a real-world context, compared with the preceding RCTs. Uneven development in endovascular technology, institutional experience and patient selection in different volumes of centres may have an impact on overall safety of this treatment. The patients were screened from December 2013 to December 2015, which was almost 10 years ago. In consideration of the development of imaging evaluation and interventional devices, the CRTICAS-2 aims to figure out the effect and safety of endovascular treatment plus medical management for sICAS patients nowadays.
Methods:
As a multicenter and prospective cohort study, it starts in December 2024, the observation is scheduled to be completed by December 2028, with a total of at least 1000 sICAS patients recruited. The information on clinical, radiological, and laboratory practices will be recorded objectively. All of the patients will be monitored until death or 12 months after the occurrence of symptomatic stroke.
Study Design:
In this study, an observational cohort will be set up. The primary outcome is the effect of endovascular treatment, which is subject to assessment using the total mortality and symptomatic stroke. The second outcome is the safety of endovascular treatment, with the postoperative ischemic complication. Based on the observation of the characteristics and outcome of sICAS patients, the ischemic events after surgery will be further addressed, and the function assessment system for operated sICAS patients will be established. We will detailedly collect the clinical data of all patients registered for the study includes medical record data; imaging examination; laboratory examination; hemodynamic evaluation and cognitive function evaluation. The imaging examination includes Magnetic Resonance Imaging(MRI), High-Resolution Magnetic Resonance Imaging(HRMRI), Computed Tomography Angiography(CTA), Magnetoencephalography (MEG) , Ultrasound and so on. The hemodynamic evaluation includes Optical CoherenceTomography (OCT), noninvasive FFR estimated from Phase Contrast Magnetic Resonance Angiography (PC-MRA) and so on. The cognitive function evaluation includes cognitive domains of verbal episodic memory, semantic verbal fluency, confrontation naming, mental processing speed-attention, executive function-cognitive flexibility and so on.
Objective:
To observe the effect of endovascular treatment plus medical therapy in patients with symptomatic intracranial atherosclerotic stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular Treatment Group | – | Procedure: Endovascular Treatmentall the participants in this group will be performed with endovascular treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All symptomatic intracranial atherosclerotic stenosis (sICAS) patients receiving endovascular treatment.
Key inclusion criteria (1 listed)
- (1)18-80 years old; (2)Received endovascular therapy during hospitalization; (3) Intracranial arterial stenosis related to the following non-atherosclerotic factors will be not be considered: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus; (4) Symptomatic intracranial stenosis: presented with transient ischemic stroke (TIA) or stroke within the past 12 months attributed to 70%-99% stenosis of a major intracranial artery (ICA, MCA [M1], vertebral artery, or basilar artery [BA]); (5) Degree of stenosis: 70%-99%; stenosis degree must be consistent with the criteria of endovascular treatment ; (6) No massive cerebral infarction (>1/2 MCA territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan; (7) Patient is willing and able to return for all follow-up visits required by the protocol; (8) Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.
Key exclusion criteria (6 listed)
- Patients had cerebrovascular diseases, e.g., intracranial aneurysm or vascular malformation, and intracranial tumors;
- History of life-threatening allergy to contrast medium. If not life threatening and can be effectively pre-treated, patient can be enrolled at physicians' discretion;
- Active bleeding diathesis or coagulopathy; active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count <125,000, hematocrit <30, Hgb <10g/dL, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia that increases the risk of bleeding, uncontrolled severe hypertension (systolic BP>180mmHg or diastolic BP>115mmHg), severe liver impairment (AST or ALT >3 times normal, cirrhosis), creatinine >265.2 mmol/L (unless on dialysis).
- Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment;
- Severe dementia or psychiatric problems that prevent the patients from following an outpatient program reliably;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular TreatmentMedical Therapy plus Stent/Balloon Angioplasty | Procedure or surgery | Endovascular Treatment Group |
Primary outcome
A composite of stroke or all-cause mortality
Time frame: Within 30 days after surgery
Stroke includes ischemic and hemorrhagic stroke, and is confirmed by postoperative imaging. Death defined as a mRS score of 6.
Stroke in the qualifying artery territory
Time frame: After surgery 3 months, 6 months and 1 year.
Including ischemic and hemorrhagic stroke, and confirmed by postoperative imaging.
8 secondary outcomes
Changes of the National Institutes of Health Stroke Scale (NIHSS) score
Time frame: After surgery 30 days, 3 months, 6 months, 1 year, 2 years and 3 years.
Changes in Modified Rankin Scale(mRS)
Time frame: After surgery 3 months, 6 months and 1 year, 2 years and 3 years.
Stroke in the qualifying artery territory
Time frame: After surgery 2 years and 3 years.
All-cause mortality
Time frame: After surgery 1 year, 2 years and 3 years.
Cognitive assessment score
Time frame: After surgery 3 months, 6 months and 1 year, 2 years and 3 years.
Serious Adverse Event
Time frame: After surgery 30days, 3 months, 6 months and 1 year, 2 years and 3 years.
EQ-5D-5L
Time frame: After surgery 1 year, 2 years and 3 years.
Self-Rating Depression Scale(SDS) or Hamilton Depression Scale(HDRS)
Time frame: After surgery 1 year, 2 years and 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Atherosclerotic Stenosis (ICAS) and Stroke, run by Xuanwu Hospital, Beijing 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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 18 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of stroke or all-cause mortality (time frame: Within 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.