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The objective of this study the first human use of a new device in treatment of acute ischemic stroke, which to evaluate the feasibility, safety, and efficacy of the Cerebrovascular Interventional Procedural Control System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Patients with acute ischemic stroke will receive interventional procedure by the Cerebrovascular Interventional Procedural Control System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebrovascular Interventional Procedural Control System | Device | The Cerebrovascular Interventional Procedural Control System is intended for use in the remote delivery and manipulation of guidewires and rapid deliver stent catheters, and remote manipulation of guide catheters during cerebrovascular intervention procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| Good Neurological Outcome | Good clinical outcome is defined as an modified Rankin Scale (mRS) score of 0-2 at 90 days. mRS 0-2 indicates functional independence 0 - No symptoms. | 90±7 Days post-treatment |
| Technical Success | Using Cerebrovascular Interventional Procedural Control System successfully complete the catheters in placement, thrombectomy stent release, and thrombectomy system recovery, without manual conversion. | Immediately post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Revascularization | Achieving mTICI ≥2b in the target vessel within 3 passes of the cerebrovascular interventional procedural control system without the use of rescue therapy. | Immediately post-treatment |
| Time from Groin Puncture to Reperfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vico Wang | Contact | +8657156105021 | neuroscience@dnamedtech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
Time from groin puncture to achievement of mTICI ≥2b |
| Immediately post-treatment |
| Successful Recanalization Rate | Achieving mTICI ≥2b in the target vessel within 1 passes of the Cerebrovascular Interventional Procedural Control System without the use of rescue therapy. | Immediately post-treatment |
| Radiation Exposure | Total fluoroscopy dose utilized during the procedure as recorded by the DSA Imaging System. | Immediately post-treatment |
| Symptomatic Intracranial Hemorrhage | Symptomatic hemorrhage within 24 hours of procedure. Symptomatic hemorrhages is defined as any parenchymal hematoma 1 (PH1), parenchymal hematoma 2 (PH2), intraparenchymal hemorrhage remote from the ischemic field (RIH), intraventricular hemorrhage (IVH), and subarachnoid hemorrhage (SAH) associated with a worsening of National Institutes of Health Stroke Scale (NIHSS) ≥ 4 within 24hrs. | 36 hours post-treatment |
| Device-related Serious Adverse Events (SAEs) | Any serious adverse events related to the device, such as vessel perforation, vessel dissection, vessel rupture, and severe spasm. | Through 90 days |
| All-cause Mortality at 90 days | Rate of mortality | Through 90 days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |