NCT05101668终止不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 10
- 主要终点
- Instant recanalization rate of target vessel after operation
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years and ≤ 85 years;
- •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);
- •Premorbid modified Rankin Scale(mRS)<2 and Pre-operation NIHSS score ≥6;
- •The patients should receive endovascular treatment within 24 hours:
- •If the treatment could happen within 6 hours, the patient should have an CT or MR
- •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.
- •Written informed consent obtained from patient or patient's legally authorized representative.
排除标准
- •Large (more than one-third of the MCA) regions of clear hypodensity on the baseline neuroimaging or significant mass effect with midline shift;
- •Any type of intracranial hemorrhage or subarachnoid hemorrhage (only microbleeds are allowed, or judge from surgeon's clinical experience) by neuroimaging;
- •Proven Simultaneous acute occlusion of both carotid artery systems, and Proven tandem lesion of simultaneous occlusion of intracranial and extracranial vessels by neuroimaging;
- •Occlusion of the common carotid artery,and known or suspected chronic occlusion of target vessel;
- •Patients with consciousness disorder with posterior circulation vascular occlusion, NIHSS score is 3 points (1a=3);
- •Proven intracranial artery occlusion due to arterial dissection or arteritis by neuroimaging;
- •Arterial tortuosity and other problems that would prevent the device from reaching the target vessel;
- •Known to have one or more of the following allergies/resistances or contraindications: antiplatelet drugs/anticoagulant drugs/contrast agents and/or anesthetics;
- •Known allergies to medical devices and related products (allergy to materials such as nickel-titanium metal or its alloys);
- •Active bleeding or known bleeding tendency (such as: anticoagulant therapy or coagulation dysfunction before surgery, international normalized ratio (INR)>3.0);
- •Baseline platelet counts<40×10^9/L;
- •Severe heart, liver or kidney failure and other serious or terminal illness;
- •Accompanied by ST-segment elevation myocardial infarction or severe infection (endocarditis or sepsis);
- •Hypertension that cannot be controlled after treatment (Baseline blood pressure>185/110 mmHg);
- •Baseline blood glucose < 2.7 or > 22.2 mmol/L. after treatment;
- •Life expectancy less than 3 months;
- •Women who are pregnant or planning to pregnancy during half a year by taking medical history);
- •Dementia or psychiatric disease that would confound the neurological or functional evaluations;
- •Current participation in another drug or device research;
- •Other special situations which the researchers believe to be not suitable for enrollment.
结局指标
主要结局
Instant recanalization rate of target vessel after operation
时间窗: Last aspiration
Instant recanalization rate (mTICI 2b-3) of target vessel after operation
次要结局
- The recanalization time of the target vessel blood flow(Procedure time (femoral artery puncture to recanalization))
- Instant recanalization rate of target vessel after the first aspiration(First aspiration)
- The success rate of device(Intraoperative)
- The incidence of symptomatic intracranial hemorrhage(24(-6/+24) hours)
- The rate of Stroke recurrence(90 days)
- Procedure-related complications(Intraoperative)
- The improvement of the postoperative NIHSS score the improvement of the postoperative NIHSS score(Change in NIHSS score at preoperative、24(-6/+24) hours、7±2 days or discharge)
- Proportion of good neurological function (mRS 0-2)(90 days)
- The success rate of operation(End of Procedure)
- All-cause death and stroke-related mortality(90 days)
- Adverse events and serious adverse events(During the clinical trials)
- The rate of device defection(Intraoperative)
研究者
研究点 (10)
Loading locations...
相似试验
终止
不适用
The Pristine Post-Market StudyHemodialysis ComplicationHemodialysis Catheter InfectionHemodialysis Access FailureCentral Venous Catheter Related Bloodstream InfectionEnd Stage Renal DiseaseKidney Failure, ChronicNCT05228132C. R. Bard142
招募中
不适用
Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal HypertensionNCT06669806C. R. Bard166
招募中
不适用
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical TrialInfrapopliteal LesionsCritical Limb IschemiaNCT05971394Biotyx Medical (Shenzhen) Co., Ltd.100
进行中（未招募）
不适用
ULTRA LONG: BioFreedom UltraHigh Bleeding Risk PatientsCoronary Artery DiseaseNCT05643430Biosensors Europe SA86
招募中
不适用
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula StenosisArteriovenous Fistula StenosisNCT06422845DK Medical Technology (Suzhou) Co., Ltd.328