Comparison of Two Validated Endovascular Strategies for Refractory Vasospastic Stenosis After Non-traumatic Intracranial Haemorrhage Leading to Severe Brain Hypoperfusion: Chemical Versus Chemical and Mechanical Angioplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in brain hypoperfusion
研究概览
简要总结
This is a monocentric randomized prospective trial comparing 2 different endovascular strategies of intracranial arterial angioplasty in case of refractory intracranial arterial vasospastic stenosis :
- chemical angioplasty
- chemical and mechanical angioplasty
详细描述
Compare in a randomized prospective trial 2 approved treatments of refractory intracranial arterial vasospastic stenosis, chemical angioplasty versus chemical and mechanical angioplasty, using devices already used in clinical practice and CE marked: chemical angioplasty using Nimotop versus chemical and mechanical angioplasty with balloon or adjustable remodeling mesh on brain perfusion evaluated by brain computed tomography (CT) Perfusion
Nowadays, the choice between chemical or chemical and mechanical angioplasty depends on the neurointerventionist for each procedure, no difference in efficiency or safety has been proved and no solid scientific data helps the physician in choosing the correct treatment for each patient.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Non-traumatic intracranial hemorrhage (ruptured aneurysm, AVM, or per-procedural complication etc)
- •Ruptured aneurysm, AVM, intracranial arterial perforation or any bleeding lesion secured with surgical clipping or endovascular intervention.
- •No contra-indication to both CTP and MRI imaging
- •Subject or legal representative is able and willing to give informed consent.
- •Refractory of intracranial arterial vasospastic stenosis requiring an endovascular angioplasty with a severe stenosis defined on CTA or DSA; and/or a significant hypoperfusion defined according to the mismatch profile in stroke or a MTT>6 seconds. The volume of critically hypoperfused tissue will be based on a time to maximum of the tissue residue function (Tmax) threshold of >6 sec using the Rapid (or equivalent) software.
排除标准
- •Angioplasty by one of the two methods considered as impossible or too risky by the neurointerventionist
- •Inability to obtain consent from patient or patients relatives
- •Pregnant women
- •Less than 18 years of age
- •Need to use any other device
- •Vertebro-basilar arteries will not be randomized because of the difficulty to assess the perfusion volume in this territory, but will be treated if necessary according to our local protocol.
研究组 & 干预措施
Chemical angioplasty
Chemical angioplasty using intra-arterial Nimodipin
干预措施: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis (Procedure)
Chemical and Mechanical angioplasty
Balloon angioplasty for refractory intracranial arterial vasospastic stenosis with a CE Marked device (Neurospeed balloon) or Adjustable remodeling mesh angioplasty for refractory intracranial arterial vasospastic stenosis with a CE Marked device (Comaneci) in association with intra-arterial Nimodipin
干预措施: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis (Procedure)
结局指标
主要结局
Change in brain hypoperfusion
时间窗: Change between day 0 and day 1 after the endovascular procedure and randomization
Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion
次要结局
- change in Brain Hypoperfusion 2(Change between day 0 and day 1 after the endovascular procedure and randomization)
- change in Glasgow coma scale(Change between day 0 and day 1 after the endovascular procedure and randomization)
- Change in the monitoring of tissue oxygen pressure (PtiO2)(Change between day 0 and day 1 after the endovascular procedure and randomization)
- Change in vessel size(Change between day 0 and day 1 after the endovascular procedure and randomization)
- Time to next endovascular intervention for vasospastic stenosis(Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks)
- Change in Transcranial Doppler(Change between day 0 and day 1 after the endovascular procedure and randomization)
- Number of new ischemic lesions(Change between day 0, 5, 9, 21 after Intracranial Hemorrhage)
- change in National Institutes of Health Stroke Scale score(Change between day 0 and day 1 after the endovascular procedure and randomization)
- Change in brain hypoperfusion 3(Change between day 0 and day 1 after the endovascular procedure and randomization)
- modified Rankin Scale at 3 months(3 months after Intracranial Hemorrhage)
- Change in brain hypoperfusion 4(Change between day 0 and day 1 after the endovascular procedure and randomization)