Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

Erasme University Hospital22 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aneurysmal Subarachnoid Hemorrhage Vasospasm, Intracranial Stenosis Ruptured Cerebral Aneurysm Arteriovenous Malformations, Cerebral Arteriovenous Fistula

Interventions

Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic StenosisPROCEDURE

Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Erasme Hospital

Brussels, Belgium

Outcomes

Primary Outcomes

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

Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization

Secondary Outcomes

Change in vessel size

Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters

Time frame: 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

Time frame: 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)

Time frame: 3 months after Intracranial Hemorrhage

Change in Transcranial Doppler

Change in intracranial vasospasm assessed by the targeted vessel velocity in meters per second

Time frame: 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

Time frame: Change between day 0 and day 1 after the endovascular procedure and randomization

change in Glasgow coma scale

Data from ClinicalTrials.gov

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