Comparison of Permanent Intracranial Stenting Versus no Stenting in Stroke Secondary to Refractory Acute Proximal Vascular Occlusion: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 346
- 试验地点
- 13
- 主要终点
- Rate of independent patients
研究概览
简要总结
Clot extraction failure during mechanical thrombectomy is a major concern in the management of acute ischemic stroke related to large vessel occlusions. Indeed, it can occur in up to 10 to 30% of cases and, therefore, is associated with a very poor prognosis. These refractory occlusions frequently occur when an underlying intracranial atherosclerotic disease is present. Thus, one of the most promising rescue technique consists of placing a permanent intracranial stent, under dual antiplatelet therapy over the target refractory occlusion. This strategy is well studied in coronary occlusions where the atheroscotic mechanism is highly prevalent. However, as the ischemiated brain is at much higher risk of hemorrhagic complications, such strategy entails a greater risk. This raises the question of whether such risk is worth the reward of obtaining reperfusion. The investigators designed this randomized study in order to evaluate whether a strategy combining rescue pemanent intracranial stenting with the best medical treatment is superior to the best medical treatment alone in acute refractory large vessel occlusions.
详细描述
These past recent years, mechanichal thrombectomy has become the standard treatment for acute ischemic strokes due to large vessel occlusions. Mechanical thrombectomy failure occurs in about 10 to 30% of cases with disastrous consequences for these patients. Indeed, reperfusion failures are associated with 30.5% mortality rates and only 21% of all patients are able to achieve functional independence at 3 months.
In order to treat these refractory large vessel occlusions many techniques and devices have been developped. Rescue Intracranial Stenting (RIS) is the most studied technique and the most promising one. However, RIS requires strong antithrombotic medications to ensure stent patency, which may increase the risk of hemorrhagic complications.
The investigators recently performed a meta-analysis of observational data, that showed that RIS in refractory large vessel occlusions allowed significant improvements in functional outcome at 3 months. The rate of good functional outcome at 3 months went from 21% in the control group (no RIS) to 43% in the RIS group. Mortality was also significantly reduced from 30.5% (control group) to 18.8% in the RIS group. Furthermore, RIS did not increase the rate of symptomatic intracranial hemorrhage.
Of course, this meta-analysis is only based on observational data and needs to be confirmed in a randomized trial to bring the highest level of evidence.
Refractory large vessel occlusions are commonly caused by an underlying intracranial atherosclerotic plaque. Since the SAMMPRIS trial, most of the indications for the endovascular treatment of intracranial atherosclerotic stenoses have been removed. Nevertheless, there are subsets of patients who actually benefit from intracranial stenting such as patients with refractory large vessel occlusions or patients with hemodynamically significant stenoses. As such, the PISTAR trial could be a way of validating intracranial stenting in this indication.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years
- •Acute ischemic stroke secondary to an occlusion of the internal carotid artery termination OR the 1st or 2nd segment of the middle cerebral artery OR the basilar artery and/or the 4th segment of the vertebral artery radiologically proven (CT Angiography or angio-MRI)
- •Patient within the authorised timeframe for a MT, according to the AHA/ASA 2019 grade I recommendations
- •Refractory intracranial large vessel occlusion defined as :
- •Persistent arterial occlusion (mTICI 0 or I) after a minimum of 3 mechanical thrombectomy passes using direct aspiration or a stent retriever OR Early arterial reocclusion (<10 minutes) after at least one pass OR Underlying stenosis (estimated between 70 and 99%)
- •ASPECT Score for CT or DWI-ASPECTS for MRI or pc(-DWI)- ASPECTS (posterior circulation) ≥ 5
- •Independent patient before stroke (mRS 0-2)
- •Patient's or her/his trusted relative's consent or emergency procedure consent
排除标准
- •Proximal intracranial vascular occlusion not confirmed on angiography
- •Intracranial bleeding <3 months or intracranial bleeding during TM procedure prior to inclusion
- •Contraindication to a dual antiplatelet therapy
- •Mechanical thrombectomy procedure requiring carotid or vertebral arterial access by direct puncture
- •Proof of significant ischemic lesions in a vascular territory not affected by the occlusion
- •Proven allergy to iodinated contrast material
- •Patient known for severe renal impairment with creatinine clearance < 30ml/min
- •Pregnant or breastfeeding women
- •Tandem occlusion (defined as the association of an intracranial occlusion to a cervical steno-occlusive lesion on the same arterial axis that needs additional endovascular manœuvers for the cervical lesion)
- •Major comorbidities that could hinder the improvement or the follow up of the patient or the benefit of the intervention
- •Unaffiliation to the French Social Security system
- •Patient under juridic protection
- •Patient participating in another interventional trial
研究组 & 干预措施
Intracranial stenting
Rescue Intracranial Stenting + best medical treatment
干预措施: Intracranial stenting (Device)
Best medical management alone
Best medical treatment with no additional thrombectomy passes
干预措施: Optimal medical care, without additional endovascular procedures (Other)
结局指标
主要结局
Rate of independent patients
时间窗: 3 months
Rate of independent patients at 3 months, defined as a modified Rankin Scale (mRS) 0-2, evaluated by a trained health professional, blinded to the randomization arm. Min=0 ; Max=6 (lower is better)
次要结局
- Intracranial hemorrhagic complications(6 months)
- Successful reperfusion(End of procedure (up to 4 hours))
- Periprocedural time (time between arterial puncture and successful reperfusion (if obtained))(End of procedure (up to 4 hours))
- modified Rankin Scale (mRS)(3 months)
- Excellent functional outcome(3 months)
- Excellent reperfusion(End of procedure (up to 4 hours))
- Periprocedural time (Time between onset of symptoms (or "last seen normal") and successful reperfusion (if obtained))(End of procedure (up to 4 hours))
- Symptomatic ischemic recurrence(3 months)
- Rate of patients requiring a new mechanical thrombectomy(3 months)
- Dissection(End of procedure (up to 4 hours))
- Embolism in a territory not previously affected by the ischemia(End of procedure (up to 4 hours))
- Serious complication on the arterial access(6 months)
- Mortality(6 months)
- Serious extracranial hemorrhagic complications(6 months)
- Neurologic recovery(72 hours)
- Periprocedural time (Time between randomization and successful reperfusion (if obtained))(End of procedure (up to 4 hours))
- Distribution of intracranial hemorrhagic complications(6 months)
- Vascular perforation(End of procedure (up to 4 hours))
- Vascular reocclusion(24 hours)
- Procedure duration(End of procedure (up to 4 hours))
- All procedural complications(Up to 6 months)
- Serious adverse events(6 months)
- Adverse events(6 months)
- Neurologic recovery(24 hours)