The NeuroVascular Research Foundation (NVRF), a 501 (c) (3) non-profit, was created in 2001. NVRF was established in order to demonstrate that endovascular therapies for emergency stroke treatment and stroke prevention improve patient outcomes. Online data collection engines (registries) are the means to accomplish this goal.
INSTOR (the INterventional Stroke Therapy Outcomes Registry) was the first registry created under the auspices of NVRF and is the first prospective interventional/endovascular stroke therapy registry in the world.
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The Foundation

The NeuroVascular Research Foundation

The NeuroVascular Research Foundation (NVRF), a 501 (c) (3) non-profit, was formed in 2001 by J. J. Connors M.D. NVRF was created specifically to demonstrate that endovascular therapies for stroke treatment and stroke prevention can produce dramatic patient benefits. In order to document clinical outcomes, as well as procedural details, patient treatment and outcomes data are captured in on-line databases (registries). INSTOR III™ (the INterventional Stroke Therapy Outcomes Registry) continues the work of the first interventional/endovascular stroke therapy registry in the world. INTRASTOR™ (the INTRcranial Angioplasty and/or STenting Outcomes Registry) was created to evaluate intracranial angioplasty for the prevention of stroke.

Registries, now mandated by all medical societies involved in stroke care as well as by the American Stroke Association, are used for Quality Assurance and Quality Improvement purposes by participating hospitals. INSTOR III™ and INTRASTOR™ are HIPAA compliant, secure, password-protected, encrypted registries that allow tracking of clinical outcomes and procedural details as well as anonymous benchmarking with other sites performing similar therapies. This not only allows confidential internal quality assessment and quality improvement operations within participating hospitals, but also allows aggregate evaluation of trends in overall stroke care and clinical outcomes, something that has never been possible in the United States.

INSTOR III™

Overview

Medical and interventional therapy of acute ischemic stroke is undergoing rapid change. In addition to the medical necessity of treating stroke effectively and efficiently, newly trained physicians are enthusiastic to treat acute stroke. However, medical knowledge cannot keep pace with new abilities, devices, techniques, or pharmaceutical agents. At present there is inadequate knowledge concerning the optimal appropriate device, technique, drug, dose, patient population or timing for emergency interventional stroke therapy even though there is increasing acknowledgment of the profound patient benefits achievable with this therapy.

PROACT II (Prolyse for Acute Thromboembolism) was the first blinded randomized endovascular trial for treatment of acute ischemic stroke and the outstanding clinical benefits were reported in 1998. The FDA has now approved the Merci retriever and the Penumbra aspiration system specifically for use in acute ischemic stroke, thus revolutionizing the treatment of stroke. While further trials are now underway, there are far more patients being treated in the United States that have no data collected at all on the specific treatment or the clinical outcomes.

INSTOR III™ (the INterventional Stroke Therapy Outcomes Registry) is a HIPAA compliant, encrypted, online database intended for internal hospital Quality Assurance and performance benchmarking against a national aggregate. It is not possible for an internal hospital database to perform this function. A registry such as this is recommended by the American Stroke Association, the Society of NeuroInterventional Surgery, The Society of Vascular and Interventional Neurology, the American Academy of Neurology, the American Society of Neuroradiology, and the Society of Interventional Radiology, and fulfills the requirements published by these organizations. INSTOR III™ is not, nor is it intended to be, a clinical trial, and is not subject to any regulatory control or obligation, similar to “Get With The Guidelines” for either heart or stroke. Results from INSTOR III™ are not intended to support approval of any product claim or indication.

Registry Objectives

The primary objective is to acquire data concerning the safety and efficacy of evolving stroke therapies and allow hospitals to track healthcare delivery and quality of care. The “coin-of-the-realm” in acute stroke care is the 3-month clinical neurological outcome, and, along with acute recanalization, is the primary clinical outcome for this registry.

Some of the specific objectives of INSTOR III™ are:

  • Record the demographics, risk factors, clinical presentation, and methods used to diagnose patients with stroke.
  • Document treatment strategies, with particular emphasis on pharmacological and mechanical or technique-based interventions
  • Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis, and treatments provided
  • Collect outcomes data on stroke patients both during initial hospitalization for stroke and at 3-months
  • Provide the ability for participating health care providers to understand and visualize their own temporal trends in practice patterns and their relation to patient outcomes
  • Facilitate quality assurance and continuing quality improvement efforts for stroke patients for hospitals
  • Provide treatment and outcomes data to facilitate development and monitoring of standard procedures and treatment guidelines
  • Provide data to allow institutions to determine the impact of differing evaluation, treatment, and management paradigms.

Methods

INSTOR III™ acquires anonymous, encrypted online data submitted by individual hospitals concerning acute stroke patients and their treatments (both intravenous and endovascular) for the purpose of internal hospital Quality Assurance and Quality Improvement. INSTOR III™ allows confidential comparison by the hospital to pre-selected data points for QA benchmarking. INSTOR III™ performs statistical analysis of the data immediately upon entry and the processes and clinical outcomes data is accumulated over time for the institution. Anonymous comparative data is available instantly to the participating hospitals on a continuing basis.

Purpose
The purpose of INSTOR III™ is to assist in Quality Assessment, Quality Assurance, and Performance benchmarking for hospitals treating stroke, and in particular, for Comprehensive Stroke Centers. The eventual goal of this database is to improve patient care by providing a tool for hospital Quality Assurance and improving clinical outcomes by: 1) assessing the impact of clinical decisions on patient outcomes, 2) evaluating the care delivery process, both individually and collectively, and 3) provide feedback for optimal critical pathways for treating stroke patients. INSTOR III™ will help physicians and hospitals determine the most appropriate and cost-effective care for optimal outcomes in patients with stroke. Secondarily, INSTOR III™ fulfills the requirements of the American Stroke Association, as well as numerous medical societies, including the American Academy of Neurology, the American Association of Neuroradiology, the Society of NeuroInterventional Surgery, the Society of Interventional Radiology, and the Society of Vascular Neurology, for data collection and analysis.