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A prospective, multicenter, stratified random, positive controlled, non-inferior clinical trial to evaluate the safety and efficacy of the Adjustable Thrombectomy Device for intravascular treatment of acute ischemic stroke

A prospective, multicenter, stratified random, positive controlled, non-inferior clinical trial to evaluate the safety and efficacy of the Adjustable Thrombectomy Device for intravascular treatment of acute ischemic stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050727
Enrollment
Unknown
Registered
2021-09-03
Start date
2021-09-08
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Interventions

Experimental group:Adjustable Thrombectomy Device

Sponsors

Changzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 85 years; 2. 6= 6 or core infarct volume < 50 mL; (2) Posterior circulation: cerebellum and occipital lobe infarction: unilateral cerebellum and occipital lobe infarction core focus < 1/2 of the largest layer (the cerebellum and occipital lobe on the same side); (3) Brainstem infarction: the core infarct area does not exceed the midline; 5. Intracranial large vessel occlusion (intracranial carotid artery, middle cerebral artery M1/M2 segment, anterior cerebral artery A1/A2 segment, basilar artery, vertebral artery intracranial segment) confirmed by DSA segment, posterior cerebral artery); 6. The subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can be followed up.

Exclusion criteria

Exclusion criteria: 1. Life expectancy 3.0 or platelet count 22.2 mmol/L that cannot be controlled by drugs; 12. Hypertension that cannot be controlled by drugs (continuous systolic blood pressure > 185mmHg, or diastolic blood pressure > 110mmHg); 13. Epilepsy accompanied by stroke; 14. Other conditions judged by the investigator to be unsuitable for inclusion. Imaging exclusion criteria (CT/MR/DSA examination with the following evidence): 1. Intracranial hemorrhage (except for microhemorrhage, the investigator will determine whether to join the group after weighing the risk according to the location and number of microhemorrhages); 2. Intracranial mass effect or intracranial tumor (except meningioma); 3. Vascular occlusion in different blood supply areas (such as bilateral anterior circulation or anterior and posterior circulation); 4. The proximal vessels of the target vessels have occlusive lesions requiring treatment; 5. Common carotid artery occlusion, known or suspected target vessel is chronic occlusion; 6. Simultaneous occlusion of bilateral carotid systems; 7. Carotid artery dissection or arteritis may be possible; 8. The vascular path is tortuous, and the test/control device is difficult to reach the target position or difficult to recover.

Design outcomes

Primary

MeasureTime frame
Rate of successful reperfusion;

Secondary

MeasureTime frame
Successful reperfusion time;NIHSS score at 24 hours and 7 days after operation;Rate of mRS (0-2) subjects at 90 days after operation;Rate of rescue therapy; First pass successful reperfusion rate;Times of thrombectomy;Operating performance of the device;

Countries

China

Contacts

Public ContactPeng Ya

Changzhou First People's Hospital

neuropengya@sina.com+86 13093178444

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026