Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group A(a self-expanding rapamycin target-eluting stent ) | Experimental | 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) |
|
| Experimental Device B(a balloon-expandable rapamycin target-eluting stent) | Experimental | 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) |
|
| Control group(Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent) | Active Comparator | 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) |
|
| Specification subgroup | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) | Device | Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months after surgery(±60days) |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success rate of stent implantation | defined as successful implantation into qualifying lesion as well as successful retraction of delivery system | Day 0(within 1hour after procedure) |
| Symptomatic ISR rate at 12 months post-procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huina Lu | Contact | +8615901703529 | HuiNa.Lu@microport.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Shanghai | Shanghai Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Overseas subgroup for Experimental Device B in Brazil | Other | 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 |
|
| Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) | Device | 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), | Device | Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China) |
|
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.
| 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. | During the days of follow-up(up to 12month ±60 days) |
| Modified Rankin Scale (mRS) score at 12 months post-procedure | 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. | 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. | During the days of follow-up(up to 12month ±60 days) |
| Study device related serious adverse event rate during follow-up | During the days of follow-up(up to 12month ±60 days) |
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided