Stroke Clinical Trial
Official title:
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
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Acotec Scientific Co., Ltd | Beijing Tiantan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target vessel stroke or death event | Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively. | within 30 days post-procedure | |
Secondary | device success rate | The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated. | assessed during procedure | |
Secondary | target vessel ischemia stroke event | The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 12 months after surgery | between 31days and 12months post-procedure | |
Secondary | Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events | Any cerebral parenchyma hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage confirmed by MRI or CT from 31 days to 12 months post procedure | between 31 days and 12 months post-procedure | |
Secondary | target vessel death event | Target-vessel related death 31 days to 12 months postoperatively | between 31 days and 12 months post-procedure | |
Secondary | National Institutes of Health Stroke Scale score | National Institutes of Health Stroke Scale score at 12 months postoperatively(0-42, higher scores mean a worse outcome) | at 12 months post-procedure | |
Secondary | Modified Rankin Score score | Modified Rankin Score at 12 months postoperatively(0-5, higher scores mean a worse outcome) | at 12 months post-procedure |
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