Chemical and Mechanical Angioplasty for Vasospasm (SAVEBRAIN)

NCT05268445 | Completed DMC

• 1 other identifier: SRB2021297
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in vessel size

  Change between day 0 and day 1 after the endovascular procedure and randomization

• Time to next endovascular intervention for vasospastic stenosis

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

• modified Rankin Scale at 3 months

  3 months after Intracranial Hemorrhage

• Change in Transcranial Doppler

  Change between day 0 and day 1 after the endovascular procedure and randomization

• change in Brain Hypoperfusion 2

  Change between day 0 and day 1 after the endovascular procedure and randomization

Study Arms (2)

Chemical angioplasty

ACTIVE COMPARATOR

Chemical angioplasty using intra-arterial Nimodipin

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

Chemical and Mechanical angioplasty

ACTIVE COMPARATOR

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

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

Interventions

Chemical and Mechanical Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis PROCEDURE

Angioplasty for Refractory Intracranial Arterial Vasospastic Stenosis

Chemical and Mechanical angioplasty; Chemical angioplasty

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial; Constriction, Pathologic; Intracranial Arteriovenous Malformations; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Intracranial Arterial Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Fistula; Fistula

Study Officials

• Adrien Guenego, MD

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization between chemical angioplasty and chemical plus mechanical angioplasty using an adjustable remodeling mesh or a balloon

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 7, 2022
• Study Start: March 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)