NCT04627870RecruitingNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Acotec Scientific Co., Ltd
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Target vessel stroke or death event
Study Overview
Brief Summary
The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Target vessel stroke or death event
Time Frame: within 30 days post-procedure
Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively.
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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