Clinical trial NCT05101668: Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in the Treatment of Acute Large-vessel Occlusive Stroke
Official title: A Prospective, Multi-center, Single-arm Objective Performance Criteria Trial to Evaluate the Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in Treatment of Acute Large-vessel Occlusive Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aspiration
Acute Ischemic Stroke
Large-vessel Occlusion
Lead sponsor: Sinomed Neurovita Technology Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, single-arm objective performance criteria
Primary purpose: TREATMENT

Brief summary: A prospective, multicenter, single-arm objective performance criteria trial to investigate the safety and efficacy of SINOMED ADPAT for Recanalization Therapy in acute large-vessel occlusive stroke.

Detailed description: This study plans to recruit 164 patients with acute intracranial large-vessel occlusion within 24 hours time window. The Primary endpoint is the instant recanalization rate of target vessel after operation. Secondary efficacy endpoints will include: 1) immediate recanalization rate of the first pass of aspiration; 2) the recanalization time of the target vessel blood flow; 3) the improvement of the postoperative NIHSS score; 4) the ratio of good neurological function (mRS 0-2 points) at 90 days; 5) the success rate of device; 6) the success rate of operation; 7) The proportion of rescue therapy. Safety endpoints will include: 1) the incidence of symptomatic intracranial hemorrhage within 24 hours after operation; 2) all-cause death and stroke-related mortality at 90 days; 3) stroke recurrence rate within 90 days after operation; 4) surgery-related complications; 5) adverse events; 6) serious adverse events; 7) Device defection rate

Eligibility criteria: Inclusion Criteria:

1. Aged ≥ 18 years and ≤ 85 years;
2. Acute ischemic stroke, patients with anterior / posterior circulation vessel occlusion (intracranial segment of internal carotid artery or M1 or M2 segment of middle cerebral artery) confirmed by digital subtraction angiography (DSA);
3. Premorbid modified Rankin Scale(mRS)\<2 and Pre-operation NIHSS score ≥6;
4. The patients should receive endovascular treatment within 24 hours:

   1. If the treatment could happen within 6 hours, the patient should have an CT or MR
   2. If the treatment could happen 6-24 hours, the patient should have an CT or magnetic resonance (MR), have an ASPECTS ≥ 6 points. If immediate CT perfusion imaging or MR perfusion imaging is feasible, CT perfusion (CTP) or magnetic resonance perfusion (MRP) should be performed at the same time to assist in the evaluation of the infarct core.
5. Written informed consent obtained from patient or patient's legally authorized representative.

Exclusion Criteria:

1. Large (more than one-third of the MCA) regions of clear hypodensity on the baseline neuroimaging or significant mass effect with midline shift;
2. Any type of intracranial hemorrhage or subarachnoid hemorrhage (only microbleeds are allowed, or judge from surgeon's clinical experience) by neuroimaging;
3. Proven Simultaneous acute occlusion of both carotid artery systems, and Proven tandem lesion of simultaneous occlusion of intracranial and extracranial vessels by neuroimaging;
4. Occlusion of the common carotid artery,and known or suspected chronic occlusion of target vessel;
5. Patients with consciousness disorder with posterior circulation vascular occlusion, NIHSS score is 3 points (1a=3);
6. Proven intracranial artery occlusion due to arterial dissection or arteritis by neuroimaging;
7. Arterial tortuosity and other problems that would prevent the device from reaching the target vessel;
8. Known to have one or more of the following allergies/resistances or contraindications: antiplatelet drugs/anticoagulant drugs/contrast agents and/or anesthetics;
9. Known allergies to medical devices and related products (allergy to materials such as nickel-titanium metal or its alloys);
10. Active bleeding or known bleeding tendency (such as: anticoagulant therapy or coagulation dysfunction before surgery, international normalized ratio (INR)\>3.0);
11. Baseline platelet counts\<40×10\^9/L;
12. Severe heart, liver or kidney failure and other serious or terminal illness;
13. Accompanied by ST-segment elevation myocardial infarction or severe infection (endocarditis or sepsis);
14. Hypertension that cannot be controlled after treatment (Baseline blood pressure\>185/110 mmHg);
15. Baseline blood glucose \< 2.7 or \> 22.2 mmol/L. after treatment;
16. Life expectancy less than 3 months;
17. Women who are pregnant or planning to pregnancy during half a year by taking medical history);
18. Dementia or psychiatric disease that would confound the neurological or functional evaluations;
19. Current participation in another drug or device research;
20. Other special situations which the researchers believe to be not suitable for enrollment.

Primary outcomes:
measure: Instant recanalization rate of target vessel after operation
timeFrame: Last aspiration
Secondary outcomes:
measure: Instant recanalization rate of target vessel after the first aspiration
timeFrame: First aspiration
measure: The recanalization time of the target vessel blood flow
timeFrame: Procedure time (femoral artery puncture to recanalization)
measure: The improvement of the postoperative NIHSS score the improvement of the postoperative NIHSS score
timeFrame: Change in NIHSS score at preoperative、24(-6/+24) hours、7±2 days or discharge
measure: Proportion of good neurological function (mRS 0-2)
timeFrame: 90 days
measure: The success rate of device
timeFrame: Intraoperative
measure: The success rate of operation
timeFrame: End of Procedure
measure: The incidence of symptomatic intracranial hemorrhage
timeFrame: 24(-6/+24) hours
measure: All-cause death and stroke-related mortality
timeFrame: 90 days
measure: The rate of Stroke recurrence
timeFrame: 90 days
measure: Procedure-related complications
timeFrame: Intraoperative
measure: Adverse events and serious adverse events
timeFrame: During the clinical trials
measure: The rate of device defection
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Qingwu Yang
city: Liuzhou
country: China
facility: LIUZHOU People's Hospital
city: Puyang
country: China
facility: Jinzhao Liu
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
city: Xiangtan
country: China
facility: Xiangtan Central Hospital
city: Xiangyang
country: China
facility: Xiang Yang No.1 Peoples Hospital
Study officials:
affiliation: The Second Affiliated Hospital of Army Medical University
name: Qingwu Yang, M.D/Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan University
name: Yimin Liu, M.D/Ph.D
role: PRINCIPAL_INVESTIGATOR
References: