Intracranial Artery Occlusion With InfarctionEarly Phase 1NCT04864691
Endovascular Recanalization and Standard Medical Management for Symptomatic Nonacute Intracranial Artery Occlusion Trial
A Early Phase 1 study testing endovascular recanalization in people with Intracranial Artery Occlusion With Infarction, run by Feng Gao at 15 sites in China.
Trial summary
Background The management of patients with symptomatic nonacute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Artery Occlusion With Infarction
- What is being tested?
- endovascular recanalization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 15 sitesChina
- Study dates
- 1 Jan 2020to 31 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥ 18 years old and life expectancy of 5 years or more.
- Symptomatic sNA-ICAO defined as:diagnosed by CTA or MRA and confirmed by angiography; Vascular occlusion time more than 24 hours;TIA or ischemic stroke (confirmed by CT or MRI) related to the LCAO despite SMT < 90 days prior to enrollment.
- Modified Rankin scale score 0-2 at the time of informed consent.
- More than one risk factor for atherosclerosis.
- For patients with ICA or MCA M1 segment occlusion, ipsilateral hypoperfusion confirmed by CTP or MRI perfusion imaging prior to enrollment and analysis by the RAPID system.
- For patients with intracranial segment occlusion of the vertebral artery, severe stenosis or occlusion of the contralateral vertebral artery.
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- Among women, no childbearing potential; or if a woman with childbearing potential, a negative pregnancy test result prior to randomization.
- Agreement of the patient to comply with all protocol-specified follow-up appointments.
- Signature by a patient of a consent form that has been approved by the local governing institutional review board (IRB)/medical ethics committee (MEC) of the respective clinical site.
Who cannot join
- Intolerance or allergic reaction to a study medication without a suitable management alternative.
- No atherosclerotic intracranial vasculopathies, such as dissection, moyamoya disease and vasculitis.
- Concomitant intracranial aneurysms or any bleeding disorder.
- Life expectancy <1 year due to other medical conditions.
- Large infarction core, defined as an ASPECTS < 6 in anterior circulation and pc-ASPECTS < 6 points in posterior circulation.
- For patients with MCA M1 segment occlusion, concomitant ≥50% stenosis of the proximal internal carotid artery or other intracranial arteries.
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- For patients with intracranial segment occlusion of the vertebral artery, continuance of the occluded vertebral artery to the posterior inferior cerebellar artery with no stump.
- Incomplete clinical and imaging data.
- Coexistent cardioembolic source (e.g., atrial fibrillation, mitral stenosis, prosthetic valve, MI within six weeks, intracardiac clot, ventricular aneurysm and bacterial endocarditis).
- Occlusive lesions with severe calcification.
- Platelet count <100,000/ml or history of heparin-induced thrombocytopenia.
- Left ventricular ejection fraction <30% or admission for heart failure in the prior 6 months.
- Extreme morbid obesity that would compromise patient safety during the procedure or the periprocedural period.
- Coronary artery disease with two or more proximal or major diseased coronary arteries with 70% stenosis that have not or cannot be revascularized.
- Anticoagulation with Marcumar, warfarin or direct thrombin inhibitors or anti-XA drugs.
- Chronic atrial fibrillation.
- Any history of atrial fibrillation or paroxysmal atrial fibrillation in the past 6 months that is considered to require long-term anticoagulant therapy.
- Other high-risk cardiogenic embolisms, including left ventricular aneurysm, severe cardiomyopathy, aortic or mitral mechanical heart valve, severe calcified aortic stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis, left atrial thrombus or any intracardiac mass or known paradoxical embolism of unrepaired PFO.
- Unstable angina defined as rest angina with ECG changes that is not amenable to revascularization (patients should undergo planned coronary revascularization at least 30 days before randomization).
- Any major surgery, major trauma, revascularization procedure or acute coronary syndrome within the past 1 month.
- serum creatinine >2.5 mg/dl or estimated GFR <30 cc/min.
- Major surgery planned within 3 months after enrollment.
- Currently listed or being evaluated for major organ transplantation (i.e., heart, lung, liver and kidney).
- Participation in other trials and may affect the results of this study.
- Inability to understand and cooperate with research procedures or provide informed consent.
- Endarterectomy, bypass or stent implantation performed on the proximal end of the occlusion vessel.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Beijing You 'anmen Hospital
Beijing, Beijing Municipality, 100054
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Liangxiang Hospital
Beijing, Beijing Municipality, 102401
Dalian Municipal Central Hospital
Dalian, Liaoning, 116033
Handan Central Hospital
Handan, Hebei, 130403
Jingjiang people's Hospital
Jingjiang, Jiangsu, 214500
ORDOS Central Hospital
Ordos, Inner Mongolia, 150603
Tong Ren Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200336
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, 050055
Tai'an Hospital of Traditional Chinese Medicine
Tai’an, Shandong, 271000
Taiyuan Central Hospital
Taiyuan, Shanxi, 030009
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030012
Taizhou first people's Hospital
Taizhou, Zhejiang, 318020
TongLiao City Hospital
Tongliao, Inner Mongolia, 028000
About this study
Official title: Department of Interventional Neurology, Beijing Tiantan Hospital, Capital Medical University
Background The management of patients with symptomatic nonacute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. Some small-sample clinical studies have also discussed endovascular recanalization for sNA-ICAO; however, there is currently a lack of evidence from multicenter, prospective, large-sample cohort trials. The aim of our present study was to evaluate the technical feasibility and safety of endovascular recanalization for sNA-ICAO.
Methods and analysis: Our group is currently undertaking a multisite, nonrandomized cohort, prospective registry study enrolling consecutive patients presenting with sNA-ICAO at 15 centers in China between May 1, 2020, and April 30, 2023. A cohort of patients who received SMT and a cohort of similar patients who received ER plus SMT were constructed and followed up for 2 years. The primary outcome is the composite of stroke/TIA within 2 years following enrollment and stroke/TIA ipsilateral to the target vessel. The secondary efficacy outcome includes the following two parts: 1) the incidence of stroke/TIA ipsilateral to the target vessel within 30 days and 90 days in both groups; 2) the all-cause mortality, mRS score, NIHSS score and cognitive function at 30 days, 90 days, 8 months, 12 months and 24 months for both groups, including the MRI, CTA/MRA, CTP or MRP results in patients with internal carotid artery or middle cerebral artery occlusion as well as CTA in patients with basilar or vertebral artery occlusion at 90 days, 12 months and 24 months. Descriptive statistics and linear/logistic multiple regression models will be generated. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat.
Ethics and dissemination This study protocol was reviewed and approved primarily by Beijing Tiantan Hospital, the Capital Medical University Medical Ethics Committee, and the institutional review boards of all partner sites. The study is being externally monitored, and the results will be published in open-access peer-reviewed scientific journals and presented to academic and policy stakeholders.
- Being tested
- endovascular recanalization
- Keywords
- standard medical therapy, symptomatic non-acute intracranial artery occlusion, endovascular recanalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular recanalizationBiological
to recanalize the occlusion cerebral artery with intravascular intervention
| Study group | Role | What they receive |
|---|---|---|
| endovascular recanalization plus standard medical treatment | Experimental | patients with symptomatic non-acute intracranial artery occlusion treated by endovascular recanalization and standard medical treatment after procedure Receives: Biological: endovascular recanalization |
| standard medical treatment | Active comparator | Patients take aspirin 100 mg/day or clopidogrel 75mg/day for the entire follow-up period (EVR patients take aspirin 100 mg/day and clopidogrel 75mg/day for 30-90 days after procedure) Receives: Biological: endovascular recanalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
The primary outcome was a composite of any stroke or death within 30 days after enrollment or ischemic stroke in the territory of the qualifying artery from 30 days to 1 year after enrollment.
Measured: One year
Secondary outcomes (2)
Incidence of Stroke/ TIA Ipsilateral to the Target Vessel
stroke/ TIA ipsilateral to the target vessel will be defined according to the World
Measured: within 30 days and 90 days in both groups
All-cause Mortality, mRS Score, NIHSS Score and Cognitive Function
to evaluate the change in all-cause mortality, mRS score, NIHSS score and cognitive function in the two groups
Measured: t 30 days, 90 days, 8 months, 12 months and 24 months for both groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Jan 2020
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial Artery Occlusion With InfarctionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Gao, Capital Medical University
- Investigators
- feng feng, professor, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864691
- Sponsor's protocol ID
- 2018AAA0102600
- Status last verified
- Jan 2025
- First submitted
- 19 Apr 2021
- Last updated
- 18 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Zhang H, Han J, Sun X, Miao Z, Guo X, Xu G, Sun Y, Wen C, Wang C, Wu Y, Xu Y, Jiang Y, Zhang S, Liu C, Li D, Liu Y, Xu C, Gao F. Endovascular Recanalization and Standard Medical Management for Symptomatic Non-acute Intracranial Artery Occlusion: Study Protocol for a Non-randomized, 24-Month, Multicenter Study. Front Neurol. 2021 Sep 28;12:729534. doi: 10.3389/fneur.2021.729534. eCollection 2021.
PubMed 34650509
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Interventional Neurology, Beijing Tiantan Hospital, Capital Medical University
- ClinicalTrials.gov ID
- NCT04864691
- Acronym / sponsor ID
- 2018AAA0102600
- Keywords
- standard medical therapy, symptomatic non-acute intracranial artery occlusion, endovascular recanalization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Posted 18 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background The management of patients with symptomatic nonacute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. Some small-sample clinical studies have also discussed endovascular recanalization for sNA-ICAO; however, there is currently a lack of evidence from multicenter, prospective, large-sample cohort trials. The aim of our present study was to evaluate the technical feasibility and safety of endovascular recanalization for sNA-ICAO.
Methods and analysis: Our group is currently undertaking a multisite, nonrandomized cohort, prospective registry study enrolling consecutive patients presenting with sNA-ICAO at 15 centers in China between May 1, 2020, and April 30, 2023. A cohort of patients who received SMT and a cohort of similar patients who received ER plus SMT were constructed and followed up for 2 years. The primary outcome is the composite of stroke/TIA within 2 years following enrollment and stroke/TIA ipsilateral to the target vessel. The secondary efficacy outcome includes the following two parts: 1) the incidence of stroke/TIA ipsilateral to the target vessel within 30 days and 90 days in both groups; 2) the all-cause mortality, mRS score, NIHSS score and cognitive function at 30 days, 90 days, 8 months, 12 months and 24 months for both groups, including the MRI, CTA/MRA, CTP or MRP results in patients with internal carotid artery or middle cerebral artery occlusion as well as CTA in patients with basilar or vertebral artery occlusion at 90 days, 12 months and 24 months. Descriptive statistics and linear/logistic multiple regression models will be generated. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat.
Ethics and dissemination This study protocol was reviewed and approved primarily by Beijing Tiantan Hospital, the Capital Medical University Medical Ethics Committee, and the institutional review boards of all partner sites. The study is being externally monitored, and the results will be published in open-access peer-reviewed scientific journals and presented to academic and policy stakeholders.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endovascular recanalization plus standard medical treatment | Experimental | Biological: endovascular recanalizationpatients with symptomatic non-acute intracranial artery occlusion treated by endovascular recanalization and standard medical treatment after procedure |
| standard medical treatment | Active comparator | Biological: endovascular recanalizationPatients take aspirin 100 mg/day or clopidogrel 75mg/day for the entire follow-up period (EVR patients take aspirin 100 mg/day and clopidogrel 75mg/day for 30-90 days after procedure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient age ≥ 18 years old and life expectancy of 5 years or more.
- Symptomatic sNA-ICAO defined as:diagnosed by CTA or MRA and confirmed by angiography; Vascular occlusion time more than 24 hours;TIA or ischemic stroke (confirmed by CT or MRI) related to the LCAO despite SMT < 90 days prior to enrollment.
- Modified Rankin scale score 0-2 at the time of informed consent.
- More than one risk factor for atherosclerosis.
- For patients with ICA or MCA M1 segment occlusion, ipsilateral hypoperfusion confirmed by CTP or MRI perfusion imaging prior to enrollment and analysis by the RAPID system.
Key exclusion criteria (26 listed)
- Intolerance or allergic reaction to a study medication without a suitable management alternative.
- No atherosclerotic intracranial vasculopathies, such as dissection, moyamoya disease and vasculitis.
- Concomitant intracranial aneurysms or any bleeding disorder.
- Life expectancy <1 year due to other medical conditions.
- Large infarction core, defined as an ASPECTS < 6 in anterior circulation and pc-ASPECTS < 6 points in posterior circulation.
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 recanalizationto recanalize the occlusion cerebral artery with intravascular intervention | Biological | endovascular recanalization plus standard medical treatment, standard medical treatment |
Primary outcome
Primary Outcome
Time frame: One year
The primary outcome was a composite of any stroke or death within 30 days after enrollment or ischemic stroke in the territory of the qualifying artery from 30 days to 1 year after enrollment.
2 secondary outcomes
Incidence of Stroke/ TIA Ipsilateral to the Target Vessel
Time frame: within 30 days and 90 days in both groups
All-cause Mortality, mRS Score, NIHSS Score and Cognitive Function
Time frame: t 30 days, 90 days, 8 months, 12 months and 24 months for both groups
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34650509Zhang H, Han J, Sun X, Miao Z, Guo X, Xu G, Sun Y, Wen C, Wang C, Wu Y, Xu Y, Jiang Y, Zhang S, Liu C, Li D, Liu Y, Xu C, Gao F. Endovascular Recanalization and Standard Medical Management for Symptomatic Non-acute Intracranial Artery Occlusion: Study Protocol for a Non-randomized, 24-Month, Multicenter Study. Front Neurol. 2021 Sep 28;12:729534. doi: 10.3389/fneur.2021.729534. eCollection 2021.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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. This study is not recruiting at the moment.
feng feng, professor study chair
Beijing Tiantan Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing endovascular recanalization in people with Intracranial Artery Occlusion With Infarction, run by Feng Gao at 15 sites 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 9 inclusion and 26 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: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: One year). 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 NCT04864691, which also lists 1 linked publication.
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 Feb 2025.