Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN) (SAVEBRAIN)

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1070
    • Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Adrien Guenego, MD, Erasme Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: February 15, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Intracranial Hemorrhages; Aneurysm; Vascular Fistula; Central Nervous System Vascular Malformations; Fistula; Hemorrhage; Constriction, Pathologic; Arteriovenous Malformations; Subarachnoid Hemorrhage; Vasospasm, Intracranial; Intracranial Aneurysm; Arteriovenous Fistula; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: SRB2021297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No