Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

Sponsor

Erasme University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05268445

Collaborator

(none)

Enrollment

Location

Arms

12.2

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Subarachnoid Hemorrhage Vasospasm, Intracranial Stenosis Ruptured Cerebral Aneurysm Arteriovenous Malformations, Cerebral Arteriovenous Fistula	Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloonRandomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 13, 2022

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Mar 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Chemical angioplasty Chemical angioplasty using intra-arterial Nimodipin	Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
Active Comparator: Chemical and Mechanical angioplasty 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 Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Arm

Intervention/Treatment

Active Comparator: Chemical angioplasty

Chemical angioplasty using intra-arterial Nimodipin

Procedure: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Active Comparator: Chemical and Mechanical angioplasty

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

Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Outcome Measures

Primary Outcome Measures

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

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
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 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.