Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

Not Applicable

Completed

• Conditions: Ruptured Cerebral Aneurysm; Aneurysmal Subarachnoid Hemorrhage; Arteriovenous Malformations, Cerebral; Arteriovenous Fistula; Vasospasm, Intracranial; Stenosis
• Interventions: Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

• Registration Number: NCT05268445
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study First Submitted: 2022-02-15
• Study First Submitted QC: 2022-02-24
• Study Start: 2022-03-01
• Study First Posted: 2022-03-07
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemical and Mechanical angioplasty	Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis	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
Chemical angioplasty	Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis	Chemical angioplasty using intra-arterial Nimodipin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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
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
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
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 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)
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
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 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

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussel, Belgium