Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

Arteriovenous Fistula Clinical Trial

— SAVEBRAIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05268445
• Other study ID #: SRB2021297
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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