Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

NCT ID: NCT05268445

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-01-01

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Vasospasm, Intracranial; Stenosis; Ruptured Cerebral Aneurysm; Arteriovenous Malformations, Cerebral; Arteriovenous Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemical angioplasty

Chemical angioplasty using intra-arterial Nimodipin

Group Type: ACTIVE_COMPARATOR

Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Intervention Type: PROCEDURE

Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Chemical and Mechanical angioplasty

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

Group Type: ACTIVE_COMPARATOR

Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Intervention Type: PROCEDURE

Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Interventions

Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrien Guenego, MD

Role: PRINCIPAL_INVESTIGATOR

Erasme hospital

Locations

Erasme Hospital

Brussels, , Belgium

Countries

Belgium

Other Identifiers

SRB2021297

Identifier Type: -

Identifier Source: org_study_id