Evaluate the Safety and Efficacy of Thrombectomy System in the Intravascular Treatment of Acute Ischemic Stroke

Hengruihongyuan Medical Technology

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: Mechanical thrombectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05719688

CRD01

Details and patient eligibility

About

Through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of Hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. According to the requirements of the experiment, 200 subjects were selected and randomly divided into the experimental group and the control group 1:1. According to the information of the group, corresponding devices were used to receive endovascular therapy and the results were evaluated.

Full description

Through the implementation of prospective, multi-center, randomized, parallel controlled clinical studies to verify the safety and effectiveness of Hongyuan thrombolysis device system in the intravascular treatment of acute ischemic stroke. According to the requirements of the trial, 200 subjects with acute ischemic stroke who met the inclusion criteria and did not meet any exclusion criteria were randomly divided into the test group and the control group at 1:1, and received endovascular therapy with corresponding instruments according to the information of the group and evaluated the results

Enrollment: 202 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-85
2. Within 8 hours of the onset of stroke symptoms
3. There are clinical signs and symptoms consistent with acute ischemic stroke
4. Imaging examination excluded intracranial hemorrhage, and there were no imaging changes of early large cerebral infarction (large infarction was defined as the aspect score of CT or DWI image < 6, infarct volume ≥70ml or infarct area > 1/3MCA)
5. Patients with imaging evidence of stroke caused by occlusion of the internal carotid artery (intracranial segment) or the M1/M2 segment of the middle cerebral artery or the A1/A2 segment of the anterior cerebral artery without clear contraindications
6. 6 points ≤NIHSS score < 30 points
7. Informed consent is signed by the patient or her legal guardian

Exclusion criteria

1. Known allergies to heparin, narcotic drugs, contrast agents, and/or antiplatelet medications such as aspirin and clopidogrel

2. mRS ≥ 2 before stroke

3. Pregnant Or Lactating Women

4. Hemorrhagic cerebrovascular history within 3 months

5. Refractory hypertension that cannot be controlled by medication (systolic blood pressure ≥185mmHg, or diastolic blood pressure ≥110mmHg)

6. Bleeding prone predisposition with severe coagulopathy, such as INR > 3.0 or platelet count < 40x10∧9/L

7. Blood glucose at screening was < 2.8mmol/L or > 22 mmol/L

8. Patients with any of the following exclusion criteria were not eligible to participate in this study

   • Preoperative CT or MRI showed bleeding symptoms
   • CT or MRI shows intracranial mass or intracranial tumor requiring surgical treatment
   • Angiography revealed carotid dissection or extracranial occlusion or arteritis of the carotid artery
   • Angiography revealed simultaneous acute obstruction of both carotid systems

9. Participate in other drug or device clinical trials within 28 days prior to screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

202 participants in 2 patient groups

Mechanical thrombectomy:Thrombectomy system

Experimental group

Description:

Subjects will be treated with Thrombectomy system,Thrombectomy system is an intraarterial thrombectomy removal device that can be re-inserted into the sheath to restore blood flow by removing blood clots in occluded vessels.

Treatment:

Device: Mechanical thrombectomy

Intracranial thrombectomy stent :Solitaire FR Revascularization Device

Active Comparator group

Description:

Subjects will be treated with Solitaire FR Revascularization Device ,the Device made by Micro Therapeutics Inc. DBA ev3 Neurovascular