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Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN) (SAVEBRAIN)

Primary Purpose

Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Intracranial, Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
Sponsored by
Erasme University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Erasme HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Chemical angioplasty

Chemical and Mechanical angioplasty

Arm Description

Chemical angioplasty using intra-arterial Nimodipin

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in vessel size
Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters
Time to next endovascular intervention for vasospastic stenosis
Delay between two procedures for the same indication
modified Rankin Scale at 3 months
clinical evolutionclinical evolution (mRS between 0 and 6, a higher score means a worse outcome)
Change in Transcranial Doppler
Change in intracranial vasospasm assessed by the targeted vessel velocity in meters per second
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 in Glasgow coma scale
Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome)
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 in the monitoring of tissue oxygen pressure (PtiO2)
Monitoring of tissue oxygen pressure (PtiO2)
Number of new ischemic lesions
Number of new ischemic lesions on non-contrast computed tomography (CT) scan
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 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

Full Information

First Posted
February 15, 2022
Last Updated
November 7, 2022
Sponsor
Erasme University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05268445
Brief Title
Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erasme University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Intracranial, Stenosis, Ruptured Cerebral Aneurysm, Arteriovenous Malformations, Cerebral, Arteriovenous Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemical angioplasty
Arm Type
Active Comparator
Arm Description
Chemical angioplasty using intra-arterial Nimodipin
Arm Title
Chemical and Mechanical angioplasty
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
Intervention Description
Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis
Primary Outcome Measure Information:
Title
Change in brain hypoperfusion
Description
Brain hypoperfusion in arterial territories assessed by the delays on perfusion Time to drain (seconds) on CT and/or MR perfusion
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization
Secondary Outcome Measure Information:
Title
Change in vessel size
Description
Change in the vessel size measured on digital subtraction angiography (DSA) and computed tomography angiogram (CTA) in millimeters
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization
Title
Time to next endovascular intervention for vasospastic stenosis
Description
Delay between two procedures for the same indication
Time Frame
Number of days after the endovascular procedure until the next procedure in days, up to 4 weeks
Title
modified Rankin Scale at 3 months
Description
clinical evolutionclinical evolution (mRS between 0 and 6, a higher score means a worse outcome)
Time Frame
3 months after Intracranial Hemorrhage
Title
Change in Transcranial Doppler
Description
Change in intracranial vasospasm assessed by the targeted vessel velocity in meters per second
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization
Title
change in Brain Hypoperfusion 2
Description
Reduction in brain hypoperfusion assessed by the volumes on different perfusion parameters time to peak (in seconds) on CT and/or MR perfusion
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization
Title
change in Glasgow coma scale
Description
Glasgow coma scale (GCS between 3 and 15, a higher score means a better outcome)
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization
Title
change in National Institutes of Health Stroke Scale score
Description
National Institutes of Health Stroke Scale (NIHSS between 0 and 42, a higher score means a worse outcome)
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization
Title
Change in the monitoring of tissue oxygen pressure (PtiO2)
Description
Monitoring of tissue oxygen pressure (PtiO2)
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization
Title
Number of new ischemic lesions
Description
Number of new ischemic lesions on non-contrast computed tomography (CT) scan
Time Frame
Change between day 0, 5, 9, 21 after Intracranial Hemorrhage
Title
Change in brain hypoperfusion 3
Description
Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters TMax maps in seconds on CT and/or MR perfusion
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization
Title
Change in brain hypoperfusion 4
Description
Brain hypoperfusion in arterial territories assessed by the delays on perfusion parameters Mean transit time on CT and/or MR perfusion in seconds
Time Frame
Change between day 0 and day 1 after the endovascular procedure and randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CUB-Hôpital Erasme Service de la Recherche biomédicale
Phone
+32 (0) 2 555 83 51
Email
mailto:Service.Rech-biomed@erasme.ulb.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Boris Lubicz, MD
Phone
3225553998
Email
Boris.Lubicz@erasme.ulb.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrien Guenego, MD
Organizational Affiliation
Erasme hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasme Hospital
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrien Guenego, MD
Email
adrienguenego@gmail.com
First Name & Middle Initial & Last Name & Degree
Boris Lubicz, MD
Email
Boris.Lubicz@erasme.ulb.ac.be
First Name & Middle Initial & Last Name & Degree
Adrien Guenego, MD
First Name & Middle Initial & Last Name & Degree
Boris Lubicz, MD
First Name & Middle Initial & Last Name & Degree
Fabio Taccone, MD
First Name & Middle Initial & Last Name & Degree
Noémie Ligot, MD
First Name & Middle Initial & Last Name & Degree
Niloufar Sadeghi, MD
First Name & Middle Initial & Last Name & Degree
Sophie Schuind, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD sharing

Learn more about this trial

Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

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