Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)
Key facts
- Who runs it
- Erasme University Hospital
- Where
- Belgium1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 22 people enrolled
- Started
- 1 Mar 2022
- Ended
- 1 Jan 2024
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
- Record updated
- 21 February 2024
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Less than 18 years of age
- 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
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is a monocentric randomized prospective trial comparing 2 different endovascular strategies of intracranial arterial angioplasty in case of refractory intracranial arterial vasospastic stenosis :
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* chemical angioplasty * chemical and mechanical angioplasty
The 2 groups in the trial
- Chemical angioplastyExisting treatment, for comparison
Chemical angioplasty using intra-arterial Nimodipin
Treatment: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
- Chemical and Mechanical angioplastyExisting treatment, for comparison
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
Treatment: Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 21 February 2024