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Clinical Trials

Explore ongoing clinical trials that make the Brain Aneurysm Institute a destination center for advanced cerebrovascular care.

Current Studies

Advancing cerebrovascular care through clinical research

Our participation in clinical research gives eligible patients access to emerging technologies while helping improve cerebrovascular care. The status shown below reflects the study at BIDMC; full study details, eligibility information, locations, and broader recruitment status are maintained on ClinicalTrials.gov.

ClinicalTrials.gov ID: NCT07214220

Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation (INSYTE)

Spryte Med Enrolling at BIDMC

INSYTE is evaluating the safety and effectiveness of an investigational neuro optical coherence tomography (nOCT) imaging system during endovascular treatment and follow-up of intracranial aneurysms. The system creates detailed images from inside a brain blood vessel to help physicians assess the vessel, aneurysm, and implanted treatment devices.

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Opens ClinicalTrials.gov

ClinicalTrials.gov ID: NCT06347796

Chronic Subdural Hematoma Treatment With Embolization Versus Surgery Study (CHESS)

NIH Enrolling at BIDMC

CHESS compares middle meningeal artery embolization with conventional surgery for moderately symptomatic chronic subdural hematoma. Researchers are studying whether embolization can reduce the need for rescue surgery or death while evaluating the safety of both treatment approaches.

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ClinicalTrials.gov ID: NCT07214623

i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study (iCURE cSDH)

Kaneka Inc Pending IRB approval

The iCURE cSDH study is evaluating treatment of chronic subdural hematoma with i-ED neuro endovascular coils, used alone or together with burr-hole drainage or mini-craniotomy when clinically appropriate. Researchers will follow participants to assess outcomes after this minimally invasive embolization procedure.

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ClinicalTrials.gov ID: NCT07260916

Minimally Invasive Neuroendoscopic Ultra-Early Targeted ICH Evacuation (MINUTE)

NIH Pending IRB approval

MINUTE compares minimally invasive endoscopic removal of a spontaneous basal ganglia intracerebral hemorrhage with standard medical treatment alone. The study is evaluating whether ultra-early clot evacuation can improve recovery, while also monitoring procedural success, complications, and longer-term outcomes.

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Opens ClinicalTrials.gov

ClinicalTrials.gov ID: NCT04195568

Evaluation of Safety and Effectiveness of the Surpass Evolve Flow Diverter System (EVOLVE)

Stryker Inc Closed to enrollment · Follow-up ongoing

EVOLVE is evaluating the safety and effectiveness of the Surpass Evolve Flow Diverter System for treating unruptured, wide-neck intracranial aneurysms measuring 12 millimeters or less in the internal carotid artery or its branches. The study follows participants after endovascular treatment to assess aneurysm closure and neurological outcomes.

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Opens ClinicalTrials.gov

ClinicalTrials.gov ID: NCT05232838

U.S. Pilot Study of the CereVasc eShunt System in Normal Pressure Hydrocephalus

CereVasc Closed to enrollment · Follow-up ongoing

This pilot study is evaluating the safety and effectiveness of the CereVasc eShunt System for normal pressure hydrocephalus. The minimally invasive system is designed to divert cerebrospinal fluid into the venous system, with participants followed to assess safety and changes in mobility, cognition, urinary symptoms, and disability.

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ClinicalTrials.gov ID: NCT06498960

Evaluation of the CereVasc eShunt System in Normal Pressure Hydrocephalus (STRIDE)

CereVasc Closed to enrollment · Follow-up ongoing

STRIDE is a randomized, multicenter study comparing the minimally invasive CereVasc eShunt System with a conventional ventriculoperitoneal (VP) shunt for normal pressure hydrocephalus. Researchers are evaluating the safety and effectiveness of both approaches for diverting cerebrospinal fluid and improving symptoms.

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Opens ClinicalTrials.gov

ClinicalTrials.gov ID: NCT06158750

PIANO Study: Flow Modulation for Intracranial Aneurysms

Wallaby Phenox Inc BIDMC status to be confirmed

PIANO is evaluating the safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device for endovascular treatment of intracranial aneurysms. The study assesses device placement, aneurysm occlusion, clinical outcomes, vessel narrowing, and neurological complications during follow-up.

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Opens ClinicalTrials.gov

Trial information and recruitment status may change. Please review each official study record for the latest information.