Comparison of Staged Angioplasty v.s. Routine Single-stage Stenting (CAS) in the Treatment of Patients With Carotid Artery Stenosis at High Risk of Hyperperfusion (STEP）: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Cerebral hyperperfusion syndrome or cerebral hemorrhage
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of staged carotid angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with carotid artery stenosis at high hyperperfusion risk in peri-procedural period.
详细描述
- Data Quality
Before the initiation of the study sites, Cerebrovascular Disease Center of Beijing Tiantan Hospital will verify whether the investigators are qualified, inspect the study site's facilities, and inform the investigators of their responsibilities, as well as how to correctly and completely fill related documents. Through investigator training sessions, the investigators and their teams will understand the trial protocol, CRF and trial process, etc. Then start-up visit at each site will be initiated.
Trial monitors will pay start-up visit to the site, and pay the first inspection visit as soon as possible after the screening/randomization of the first patient. Afterwards, the monitors will pay inspection visits regularly until the trial visits end. They need to directly refer to source data to verify the accurate of CRF filling and conduct inspection/audits.
Data entered into the CRF shall be subject to examination of internal consistency (within known classification and scope), external inspection (data are consistent with the patient's other known data) and trend consistency (data changes do not exceed the allowable range. For example, excess weight loss prompts changes in dietary status). The contents of trial database include data collected by each site, abnormal data and delayed data in progress tracking. 2. File Data
Data entered into the CRF must be able to be verified by source data, or directly entered into the CRF. In this case, the data in the CRF can be regarded as source data, and used for subsequent data confirmation. Required data of all patients' continued treatment shall also be routinely recorded in their medical records. The site's investigators shall clearly make patients' medical records that the patient is participating in a clinical trial, and also require any other medical staff for treatment of the patient to contact the trial contact persons before treatment. To this end, the investigators shall provide their contact information. If a patient preserves his/her medical records on his/her own, the study site shall preserve a copy of all trial-related data. Unless related data or information is directly recorded in the CRF, all research data must be recorded in patients' medical records (or research documents), and entered into the CRF as early as possible. Source data to be verified and primary documents used for such purpose must be preserved. Patients' research documents and all source data shall be preserved until a notice for destruction is received from the sponsor. 3. Statistical Method and Sample Size
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 40~80 years of age
- •Patient with symptomatic carotid stenosis (defined as stroke/TIA of the patient within 90 days while he/she is taking at least one antithrombotic drug or under other intervention on vascular risk factors like hypertension or hyperlipidemia)
- •DSA shows percent carotid stenosis≥90% (quantification of the stenosis according to NASCET method); or near occlusion
- •Angiogram shows insufficient collateral circulation in the culprit vessel surrounding area:
- •Cerebral CT perfusion imaging shows hypo-perfusion of the culprit vessel surrounding area, and
- •DSA shows collateral circulation assessment < 2, and
- •MRI cerebral imaging shows hemodynamic ischemic lesion
- •CT perfusion imaging shows cerebral blood flow of the culprit side is of 20% lower than the other lateral brain
- •Lesion length at the narrowest part < 25mm
- •Note: Grading of angiographic collateral circulation
- •Grade 0: No collateral circulation in the area dominated by the culprit vessel
- •Grade 1: Slow collateral circulation in the surrounding areas, but filling defects exist
- •Grade 2: Fast collateral circulation, but some areas still have filling defects
- •Grade 3: Collateral circulation is slow, but complete filling can be seen in the vein at a late stage
- •Grade 4: Complete and fast collateral circulation, without any filling defect
排除标准
- •Diffusive stenosis of the cerebral artery
- •MRI cerebral imaging shows perforating artery occlusion
- •Cerebral hemorrhage at the culprit vessel surrounding area within 6 weeks; potential thrombus from the heart
- •Subsequent cerebral tumor, cerebral aneurysm, or arteriovenous abnormality
- •Known contraindication to heparin, aspirin, ticlopidine, a aesthetic, and contrast; blood hemoglobin < 10g/dl, blood platelet < 100000
- •Severe nerve dysfunction in the culprit vessel surrounding area after a cerebral infarction (mRS≥3)
- •INR > 1.5 (irreversible), uncorrectable bleeding risk factors, life expectancy < 1 year
- •Women in pregnant or breast feeding
- •Committee adjudicating the inclusion criteria finds the patient is unsuitable for the staged angioplasty for carotid artery stenosis
- •Unsuccessful placement of proximal or distal EPD during the procedure
- •The target vessel angle≧45
- •Participate in other clinical trials within three months
研究组 & 干预措施
Routine single-stage CAS
Using a balloon, stent
Routine stenting procedure:
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield); Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation; After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
干预措施: a balloon, stent (Device)
Staged angioplasty
Using Abbott EPD systems (Accunet/Emboshield), a balloon, stent
Method of stage-1 angioplasty
The stent can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield) if distal filter cannot be used, balloon angioplasty can be performed under proximal protection device; Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis <70%.
Method of stage-2:
The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield); Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation; After the placement of stent, the angioplasty is a success when residual stenosis is <30%.
干预措施: Abbott EPD systems (Accunet/Emboshield), a balloon, stent (Device)
结局指标
主要结局
Cerebral hyperperfusion syndrome or cerebral hemorrhage
时间窗: Within 30 days after CAS procedure or after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure.
* Staged angioplasty arm: cerebral hyperperfusion syndrome or cerebral hemorrhage within 30 days after stage-1 balloon angioplasty procedure and after stage-2 CAS procedure. * Regular single-stage CAS arm: cerebral hyperperfusion syndrome or cerebral hemorrhage within 30 days after CAS procedure
次要结局
- Acute success of the culprit vessel after stage-1 balloon angioplasty (Diameter stenosis < 70%).(one year)
- Cerebral hyperperfusion syndrome attributed to non-culprit vessels within 30 days to 1 year post procedure.(one year)
- Any intracerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage within 30 days to 1 year post procedure.(one year)
- Cerebral hyperperfusion syndrome or cerebral hemorrhage attributed to the target vessel within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure.(within 30 days after stage-1 balloon angioplasty or stage-2 CAS procedure)
- Myocardial infarchtion (MI)(one year)
- Stoke resulting in deformity(one year)
- Any stroke or death(one year)
- Major non-stroke hemorrhage (eg. Epidural hemorrhage, intradural hemorrhage, or other major systemic bleedings)(one year)
- Death at 30 days post procedure(one year)
研究者
Zhongrong Miao
Director of Department of Intervention
Beijing Tiantan Hospital