Trials / Completed
CompletedNCT05268445
Chemical and Mechanical Angioplasty for Vasospasm (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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Erasme University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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
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.
Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Vasospasm, Intracranial
- Stenosis
- Ruptured Cerebral Aneurysm
- Arteriovenous Malformations, Cerebral
- Arteriovenous Fistula
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis | Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis |
Timeline
- Start date
- 2022-03-01
- Primary completion
- 2024-01-01
- Completion
- 2024-01-01
- First posted
- 2022-03-07
- Last updated
- 2024-02-21
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05268445. Inclusion in this directory is not an endorsement.