NCT04627870招募中不适用
A Prospective, Multi-center, Randomized Controlled Trial to Evaluate the Safety and Feasibility of Intracranial Drug-coated Balloon Catheter in the Treatment of Intracranial In-stent Restenosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Target vessel stroke or death event
研究概览
简要总结
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
详细描述
This study is a prospective, multi-center, randomized controlled trial using drug coated balloon versus uncoated PTA balloon in treatment of intracranial in-stent restenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 80 years of age
- •Confirmed by DSA: in-stent restenosis (ISR) at intracranial segment of internal carotid artery, middle cerebral artery, basilar artery and vertebral artery; ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss
- •presence of ISR associated ischemic stroke or transient ischemic attacks even with medical treatment and strict control of risk factor
- •asymptomatic ISR with severe hypoperfusion in the ISR territories, confirmed by a cerebral blood flow decrease of ≥30% when compared with the perfusion on the contralateral side for anterior circulation lesions or the anterior circulation territory for posterior circulation lesions on CT perfusion, and/or by an American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) Collateral Flow Grading System score <3 on DSA.
- •the diameter of target vessel is 2.0-4.5mm
- •there is only one intracranial ISR lesion per subject
- •baseline mRS score ≤2
- •Voluntarily participate in this study and sign the informed consent form
排除标准
- •Patients with stroke within 2 weeks before procedure;
- •any history of brain parenchyma or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days.
- •Those who have received thrombolysis within 24 hours before procedure;
- •Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline)
- •patients with thrombus in target vessels.
- •in addition to ISR lesions, there are other primary intracranial lesions that need endovascular treatment.
- •Major surgery (including open femoral, aortic or carotid artery surgery) is planned within the past 30 days or within 90 days.
- •patients with renal artery, iliac artery and cardiac coronary artery requiring simultaneous intervention.
- •Combined with intracranial tumors, aneurysms or intracranial arteriovenous malformations.
- •Cardiac stroke or potential cardiogenic thromboembolism, with any of the following cardiogenic embolism causes: chronic or paroxysmal atrial fibrillation, mitral valve stenosis, mechanical valves, endocarditis, intracardiac thrombus or implant, dilated cardiomyopathy, spontaneous acoustic imaging of the left atrium;
- •patients with myocardial infarction within 6 weeks before procedure.
- •those who cannot tolerate general anesthesia due to insufficiency of heart, lung and other important organs.
- •patients with known severe hepatic and renal dysfunction.
- •patients with hemoglobin < 100g / L, platelet count < 100,000 / mm3, INR > 1.5or with uncorrectable factors leading to bleeding.
- •patients who cannot receive dual antiplatelet therapy due to existing diseases or who are tested to be tolerant to dual antiplatelet therapy.
- •Patients with known severe allergies or contraindications to heparin, paclitaxel, contrast agents and other related intravascular treatment drugs
- •current alcohol or drug abuse, uncontrolled severe hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure > 110mmHg).
- •Life expectancy < 1 year.
- •pregnant or lactating women.
- •patients who are unable to complete follow-up due to cognitive, emotional disorders or mental illness.
- •Patients who are participating in other drug/device clinical trials and have not completed all follow-ups required by the programme;
- •According to the judgement of the investigator, other situations that are not suitable for enrollment
结局指标
主要结局
Target vessel stroke or death event
时间窗: within 30 days post-procedure
Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.
次要结局
- Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events(between 31 days and 12 months post-procedure)
- device success rate(assessed during procedure)
- target vessel ischemia stroke event(between 31days and 12months post-procedure)
- target vessel death event(between 31 days and 12 months post-procedure)
- National Institutes of Health Stroke Scale score(at 12 months post-procedure)
- Modified Rankin Score score(at 12 months post-procedure)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
A Trail of Drug-coated Balloon Treating Below The Knee Arterial DiseasesPeripheral Artery DiseaseNCT05415995Zhejiang Zylox Medical Device Co., Ltd.202
进行中（未招募）
不适用
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) TrialDrug-coated BalloonDrug-eluting StentDe Novo StenosisNCT06084000China National Center for Cardiovascular Diseases2,700
已完成
不适用
Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation LesionsCoronary DiseaseNCT03223974Beijing Hospital80
Unknown
不适用
Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D LesionsPADNCT03129750Ettore Sansavini Health Science Foundation150
已完成
不适用
Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent RestenosisCoronary RestenosisNCT02944890ZhuHai Cardionovum Medical Device Co., Ltd.242