Status:
COMPLETED
Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)
Lead Sponsor:
Erasme University Hospital
Conditions:
Aneurysmal Subarachnoid Hemorrhage
Vasospasm, Intracranial
Eligibility:
All Genders
18-100 years
Phase:
NA
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 :...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05268445
Start Date
March 1 2022
End Date
January 1 2024
Last Update
February 21 2024
Active Locations (1)
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1
Erasme Hospital
Brussels, Belgium, 1070