IRRAS Accounces Announces First Patient Enrolled in ARCH Study, a Comparative Clinical Trial Designed to Confirm IRRAflow’s Ability to Improve Clearance of Clot after IVH
Stockholm, October 28, 2021 - IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the initial patient enrollment in the ARCH (Active Removal of IntraCerebral Hematoma via active irrigation of ventricular system) clinical trial. The ARCH study will compare the ability of the company’s IRRAflow system to clear the blood collected in a patient’s ventricles after an intraventricular hemorrhage (IVH) more effectively than traditional passive drainage. The ARCH investigators hypothesize that IRRAflow’s active irrigation, when combined with thrombolytic medication, will reduce the time needed to clear blood from the intraventricular space, thereby improving patient outcomes.
The ARCH study is a controlled, randomized clinical trial that is expected to enroll 60 patients across a number of sites in both Europe and the United States. The team at Helsinki University Hospital, led by neurosurgeon Dr. Behnam Rezai Jahromi and Dr. Jari Siironen, Head of Neurosurgical ICU, will lead the international collection of leading neurosurgical centers that will participate in the study.
"We are extremely excited to start and lead the international ARCH clinical study and confirm that using irrigation to deliver medication can actively change the composition of cerebrospinal fluid (CSF) and improve the poor prognosis of patients with IVH,” said Dr. Rezai Jahromi. “Our encouraging preliminary data was recently presented at the Congress of Neurological Surgeons (CNS) 2021 annual meeting, and we believe that the ARCH study can build upon these results and have a tremendous impact on IVH treatment decisions.”
The study’s three-arm design will compare IRRAflow versus traditional ventricular drainage when treating IVH in conjunction with tissue plasminogen activator (tPA), a medication used in stroke to dissolve clot.
- Arm 1 – Use of standard, passive EVD with manual bolus introduction of tPA according to the protocol outlined in the previously published CLEAR trial series.
- Arm 2 – Use of IRRAflow system with manual bolus introduction of tPA according to the CLEAR protocol, followed by IRRAflow’s active irrigation.
- Arm 3 – Use of IRRAflow system with continuous infusion of tPA via IRRAflow’s active irrigation mechanism of action.
Additional sites are expected to be added to the ARCH study in coming months, and patient enrollment is expected to continue throughout 2022. The trial has been designed for interim results to be announced at various intervals during patient enrollment.
“The initiation of the ARCH study is pivotal inflection point in the growth of IRRAS,” said Will Martin, President and CEO of IRRAS. “Early adopters of the system believe IRRAflow is a transformational step forward in improving IVH outcomes, and, now, our company is investing in the comparative data that will serve as a critical next step toward making IRRAflow a standard of care.”
IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.
IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.
IRRAS is listed on Nasdaq Stockholm (ticker: IRRAS).
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The information was released for public disclosure, through the agency of the contact person above, on October 28, 2021 at 08:30 (CET).