A Phase 3 interventional study of Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) and Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) in Intracranial Arteriosclerosis, sponsored by MicroPort NeuroTech Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-13.
Sponsored by MicroPort NeuroTech Co., Ltd. (formerly part of MicroPort Scientific Corporation) · Phase 3, Interventional, and Treatment
Among 44 studies in Intracranial Arteriosclerosis with a site in China — 28 open to participants now, 28 under way, 2 of them phase 3. Intracranial Arteriosclerosis · China.
Among the 44 studies in Intracranial Arteriosclerosis with a site in China, this one is the 11th largest by planned enrollment of the 27 interventional ones that give a count, is one of 3 that started in 2025, is one of 2 in phase 3, reaches primary completion later than 19 of the 27 other live ones, and was the 39th registered.
102 studies on the registry are indexed under Intracranial Arteriosclerosis; 48 are open to participants now.
Browse Intracranial Arteriosclerosis studies →28 of the 44 studies in Intracranial Arteriosclerosis with a site in China are open now. Recruiting first, the newest first:
Xuanwu Hospital, Beijing · Sites in China
Ages 18–80
Peking Union Medical College Hospital · Sites in China
Ages 18–80
Xuanwu Hospital, Beijing · Sites in China
Ages 18+ · Healthy volunteers
Qianfoshan Hospital · Sites in China
Ages 18–80
Fujian Medical University Union Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 28 Intracranial Arteriosclerosis studies recruiting now, 11 (39%) set no upper age limit and 1 (4%) stops at 75 or younger; none take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 3 · Phase 4 8
First in 2007; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 279 is above the median of 194 across 61 interventional studies indexed under Intracranial Arteriosclerosis.
Median enrollment 200 across the 27 interventional studies, 300 across the 17 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 44 have an industry lead sponsor. The 10 most frequent:
This study is registered under MicroPort NeuroTech Co., Ltd., one of the names counted as MicroPort Scientific Corporation. Under that name alone:
MicroPort NeuroTech Co., Ltd. is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
MicroPort Scientific Corporation has 1 study filed under Intracranial Arteriosclerosis — fewer than ten, so there is no comparison to draw.
6 of the studies in Intracranial Arteriosclerosis with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06925971Phase 3MicroPort NeuroTech Co., Ltd.A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM） | 2027-10-01 |
| NCT07445581Jinggang Xia, MDTanhuo Decoction for Acute Coronary Syndrome With Cerebral Atherosclerosis in Elderly Patients | 2026-12-31 |
| NCT06881420Fujian Medical University Union HospitalBASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease | 2026-12-31 |
| NCT05550077jiaoliqunOptical Coherence Tomography for Intracranial Atherosclerotic Stenosis | 2026-12-31 |
| NCT07927569Qianfoshan HospitalIntegrated PET/MR Assessment of Brain Recovery After Recanalization of Non-Acute Atherosclerotic MCA Occlusion | 2027-01-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 44 studies in Intracranial Arteriosclerosis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The trial is a prospective, multicenter, open-label, superiority, randomized controlled clinical trial. The experimental groups include two types of drug-eluting stents:
Considering the broader applicability of Experimental Device A and Experimental Device B compared to the control device, a specification subgroup is established. 20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing.
Moreover, a subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration.
Overall, the total sample size for the study is 279 subjects. Clinical assessment will be conducted for all subjects before the procedure, during the procedure, at discharge, at 1 month (±7 days) follow-up, at 6 months (±30 days) follow-up, and at 12 months (±60 days) follow-up. At 12 months (±60 days), patients will undergo follow-up with DSA imaging. Unscheduled follow-ups may be performed as needed to record relevant indicators and evaluate the safety and efficacy of the two drug-eluting stents in the treatment of symptomatic cerebral artery atherosclerotic stenosis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A（total 249 subjects in randomization group in China）
Device: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group B（total 249 subjects in randomization group in China）
Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Approximately 83 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to control group（total 249 subjects in randomization group in China）
Device: Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),
20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing.
Device: Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) · Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
A subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration
Device: Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China)
In-stent restenosis (ISR) rate at 12 months post-procedure
ISR is defined as \>50% stenosis within or adjacent (within 5 mm) to the stent as well as \>20% absolute luminal loss according to the WASID method diagnosed by DSA
Time frame: 12 months after surgery(±60days)
Technical success rate of stent implantation
defined as successful implantation into qualifying lesion as well as successful retraction of delivery system
Time frame: Day 0（within 1hour after procedure）
Symptomatic ISR rate at 12 months post-procedure
ISR (ISR is defined as \>50% stenosis within or adjacent (within 5 mm) to the stent as well as \>20% absolute luminal loss according to the WASID method diagnosed by DSA) occurs with ischemic stroke or TIA from target lesion restenosis. Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction. TIA is defined as transient focal neurological dysfunction from brain/spinal cord/retinal ischemia, with symptoms lasting\<24 hours and no acute infarction.
Time frame: 12 months after surgery(±60days)
Revascularization rate from qualifying artery at 12 months post-procedure
During follow-up, revascularization procedures (including interventional thrombectomy, angioplasty, vascular bypass, etc.) due to ischemic stroke or TIA from target lesions. Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction. TIA is defined as transient focal neurological dysfunction from brain/spinal cord/retinal ischemia, with symptoms lasting\<24 hours and no acute infarction.
Time frame: During the days of follow-up(up to 12month ±60 days)
Modified Rankin Scale (mRS) score at 12 months post-procedure
Time frame: 12 months after surgery(±60days)
Stroke or death related to qualifying lesion at 30 days, 6 months, and 12 months post-procedure
Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction.
Time frame: During the days of follow-up(up to 12month ±60 days)
Any stroke or death at 30 days, 6 months, and 12 months post-procedure
Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction.
Time frame: During the days of follow-up(up to 12month ±60 days)
Study device related serious adverse event rate during follow-up
Time frame: During the days of follow-up(up to 12month ±60 days)
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for Oct 2027, 29 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Intracranial Arteriosclerosis →
MicroPort NeuroTech Co., Ltd. →