Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Intracranial, Stenosis, Ruptured Cerebral Aneurysm, Arteriovenous Malformations, Cerebral, Arteriovenous Fistula

Intervention / Treatment
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* Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemical angioplasty<br>Chemical angioplasty using intra-arterial Nimodipin | Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis<br>* Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis<br>|
| Active Comparator: Chemical and Mechanical angioplasty<br>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 | Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis<br>* Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain hypoperfusion | Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion | Change between day 0 and day 1 after the endovascular procedure and randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vessel size | Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters | Change between day 0 and day 1 after the endovascular procedure and randomization | 
| Time to next endovascular intervention for vasospastic stenosis | Delay between two procedures for the same indication | Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks | 
| modified Rankin Scale at 3 months | clinical evolutionclinical evolution (mRS between 0 and 6, a higher score means a worse outcome) | 3 months after Intracranial Hemorrhage | 
| Change in Transcranial Doppler | Change in intracranial vasospasm assessed by the targeted vessel velocity in meters per second | Change between day 0 and day 1 after the endovascular procedure and randomization | 
| change in Brain Hypoperfusion 2 | Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion | Change between day 0 and day 1 after the endovascular procedure and randomization | 
| change in Glasgow coma scale | Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome) | Change between day 0 and day 1 after the endovascular procedure and randomization | 
| change in National Institutes of Health Stroke Scale score | National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome) | Change between day 0 and day 1 after the endovascular procedure and randomization | 
| Change in the monitoring of tissue oxygen pressure (PtiO2) | Monitoring of tissue oxygen pressure (PtiO2) | Change between day 0 and day 1 after the endovascular procedure and randomization | 
| Number of new ischemic lesions | Number of new ischemic lesions on non-contrast computed tomography (CT) scan | Change between day 0, 5, 9, 21 after Intracranial Hemorrhage | 
| Change in brain hypoperfusion 3 | Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion | Change between day 0 and day 1 after the endovascular procedure and randomization | 
| Change in brain hypoperfusion 4 | Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds | Change between day 0 and day 1 after the endovascular procedure and randomization |