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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemical angioplasty | Active Comparator | Chemical angioplasty using intra-arterial Nimodipin |
|
| Chemical and Mechanical angioplasty | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis | Procedure | Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrien Guenego, MD | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Brussels | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41962956 | Derived | Guenego A, Salim HA, Taccone FS, Heit JJ, Wang M, Sadeghi N, Ligot N, Wintermark M, Tannouri F, Lubicz B; SAVEBRAIN Consortium. Chemical Angioplasty Alone versus Chemical and Mechanical Angioplasty for Cerebral Vasospasm after Aneurysmal Hemorrhage: A Pilot Randomized Controlled Study. AJNR Am J Neuroradiol. 2026 Jul 1;47(7):1824-1831. doi: 10.3174/ajnr.A9194. |
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No IPD sharing
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Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon
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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 |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D020301 | Vasospasm, Intracranial |
| D003251 | Constriction, Pathologic |
| D002538 | Intracranial Arteriovenous Malformations |
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020763 | Pathological Conditions, Anatomical |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016157 | Vascular Fistula |
| D005402 | Fistula |
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