Clinical trial NCT05268445: Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Vasospasm, Intracranial
Stenosis
Ruptured Cerebral Aneurysm
Arteriovenous Malformations, Cerebral
Arteriovenous Fistula
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in brain hypoperfusion
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
Secondary outcomes:
measure: Change in vessel size
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
measure: Time to next endovascular intervention for vasospastic stenosis
timeFrame: Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
measure: modified Rankin Scale at 3 months
timeFrame: 3 months after Intracranial Hemorrhage
measure: Change in Transcranial Doppler
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
measure: change in Brain Hypoperfusion 2
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
measure: change in Glasgow coma scale
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
measure: change in National Institutes of Health Stroke Scale score
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
measure: Change in the monitoring of tissue oxygen pressure (PtiO2)
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
measure: Number of new ischemic lesions
timeFrame: Change between day 0, 5, 9, 21 after Intracranial Hemorrhage
measure: Change in brain hypoperfusion 3
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
measure: Change in brain hypoperfusion 4
timeFrame: Change between day 0 and day 1 after the endovascular procedure and randomization
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme hospital
name: Adrien Guenego, MD
role: PRINCIPAL_INVESTIGATOR
References: