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Completed

NCT Number: NCT05268445

Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

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

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Arteriovenous Fistula Arteriovenous Malformations Arteriovenous Malformations, Cerebral Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Vascular Malformations Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constriction, Pathologic Fistula Hemorrhage Intracranial Arterial Diseases Intracranial Arteriovenous Malformations Intracranial Hemorrhages Nervous System Diseases Nervous System Malformations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ruptured Cerebral Aneurysm Stenosis Subarachnoid Hemorrhage Vascular Diseases Vascular Fistula Vascular Malformations Vasospasm, Intracranial

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Procedure

Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Primary outcomes

  1. Change in brain hypoperfusion

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

    Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion

Secondary outcomes

  1. Change in vessel size

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

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

  2. Time to next endovascular intervention for vasospastic stenosis

    Time frame: Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks

    Delay between two procedures for the same indication

  3. modified Rankin Scale at 3 months

    Time frame: 3 months after Intracranial Hemorrhage

    clinical evolutionclinical evolution (mRS between 0 and 6, a higher score means a worse outcome)

  4. Change in Transcranial Doppler

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

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

  5. change in Brain Hypoperfusion 2

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

    Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion

  6. change in Glasgow coma scale

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

    Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome)

  7. change in National Institutes of Health Stroke Scale score

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

    National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome)

  8. Change in the monitoring of tissue oxygen pressure (PtiO2)

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

    Monitoring of tissue oxygen pressure (PtiO2)

  9. Number of new ischemic lesions

    Time frame: Change between day 0, 5, 9, 21 after Intracranial Hemorrhage

    Number of new ischemic lesions on non-contrast computed tomography (CT) scan

  10. Change in brain hypoperfusion 3

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

    Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion

  11. Change in brain hypoperfusion 4

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

    Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study 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

Acronym: SAVEBRAIN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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