Evaluation of Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation

Completed

Conditions studied: Cerebral Hemorrhage

In brief

Intracerebral hemorrhage (ICH) is the most severe form of stroke: early mortality is 40%, and 80%-of survivors are physically disabled with high rates of cognitive impairment and depression. In an effort to address the issues with conventional treatments, a new integrated systematic approach has been developed. This approach utilizes an educational process where specific core competencies (pillars) of mapping, navigation, access, optics and automated resection have been integrated into a single standardized system to deliver targeted therapy for an individual patient based on location and patient factors. This system has demonstrated safety and efficacy in oncology patients and is also FDA approved for use in the ICH patient population as well. This registry will collect data form multiple site that preform the MiSPACE procedure as part of clinical care. The intent of this registry is to collect data on the economic impact as well as clinical outcomes using the MiSPACE approach with the integrated technology in the early treatment of ICH.

Key facts

Study ID

NCT02331719

Run by

Wake Forest University Health Sciences

People needed

16

Starts

2014-08-01

Expected to finish

2017-10-01

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presented with acute symptomatic supratentorial primary ICH diagnosed by CT
• Has made the clinical treatment decision to have parafascicular minimally invasive subcortical (MIS) access to treat subcortical intracerebral hemorrhage (ICH) using the systems approach outlined in this protocol
• 18 - 80 years old
• Symptom onset to surgery < 24 hours (target < 8hours)
• Presurgical Glascow Coma Score ≥ 8
• Hematoma volume < 60ml
• Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)

You may not qualify if…

• Suspected secondary ICH
• Infratentorial ICH
• Isolated IVH
• Uncorrected coagulopathy
• Significant premorbid disability (mRS>1)
• Hydrocephalus
• Contraindication to safe surgical procedure

Where it is running

• University Of Arkansas of Medical Sciences — Little Rock, Arkansas, United States
• University of Colorado — Aurora, Colorado, United States
• Emory University at Grady Memorial Hospital — Atlanta, Georgia, United States
• OSF Saint Francis Medical Center — Peoria, Illinois, United States
• IU Health Neuroscience Center — Indianapolis, Indiana, United States
• St. Louis University — St Louis, Missouri, United States
• Riverside Methodist Hospital (OhioHealth) — Columbus, Ohio, United States
• Aurora Health Care, Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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