Aneurysmal Subarachnoid Hemorrhage, Arteriovenous Fistula, Arteriovenous Malformations, Cerebral, Ruptured Cerebral Aneurysm, Stenosis, Vasospasm, Intracranial
Conditions
Brief summary
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
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.
Interventions
PROCEDUREChemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Non-traumatic intracranial hemorrhage (ruptured aneurysm, AVM, or per-procedural complication etc) 3. Ruptured aneurysm, AVM, intracranial arterial perforation or any bleeding lesion secured with surgical clipping or endovascular intervention. 4. No contra-indication to both CTP and MRI imaging 5. Subject or legal representative is able and willing to give informed consent. 6. 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
1. Angioplasty by one of the two methods considered as impossible or too risky by the neurointerventionist 2. Inability to obtain consent from patient or patients relatives 3. Pregnant women 4. Less than 18 years of age 5. Need to use any other device 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in brain hypoperfusion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Delay between two procedures for the same indication |
| modified Rankin Scale at 3 months | 3 months after Intracranial Hemorrhage | clinical evolutionclinical evolution (mRS between 0 and 6, a higher score means a worse outcome) |
| Change in Transcranial Doppler | Change between day 0 and day 1 after the endovascular procedure and randomization | Change in intracranial vasospasm assessed by the targeted vessel velocity in meters per second |
| change in Brain Hypoperfusion 2 | Change between day 0 and day 1 after the endovascular procedure and randomization | Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion |
| change in Glasgow coma scale | Change between day 0 and day 1 after the endovascular procedure and randomization | Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome) |
| Change in vessel size | Change between day 0 and day 1 after the endovascular procedure and randomization | Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters |
| Change in the monitoring of tissue oxygen pressure (PtiO2) | Change between day 0 and day 1 after the endovascular procedure and randomization | Monitoring of tissue oxygen pressure (PtiO2) |
| Number of new ischemic lesions | Change between day 0, 5, 9, 21 after Intracranial Hemorrhage | Number of new ischemic lesions on non-contrast computed tomography (CT) scan |
| Change in brain hypoperfusion 3 | Change between day 0 and day 1 after the endovascular procedure and randomization | Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion |
| Change in brain hypoperfusion 4 | Change between day 0 and day 1 after the endovascular procedure and randomization | Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds |
| change in National Institutes of Health Stroke Scale score | Change between day 0 and day 1 after the endovascular procedure and randomization | National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome) |
Countries
Belgium
Outcome results
None listed