Imperative Care Launches ADAPT 2.0 Study to Advance Stroke Treatment with Streamlined Aspiration Technique
Imperative Care, a medical technology company dedicated to improving outcomes for patients with vascular diseases, has announced the enrollment of the first patients in its ADAPT 2.0 Clinical Study. This major clinical initiative is focused on evaluating a refined thrombectomy technique designed to simplify and enhance the treatment of acute ischemic stroke—one of the leading causes of death and long-term disability worldwide.
The ADAPT 2.0 study represents a significant step forward in the ongoing effort to improve stroke intervention by combining innovative procedural techniques with advanced medical devices, specifically the Zoom Stroke System. By focusing on both efficiency and effectiveness, the study aims to generate meaningful clinical data that could shape the future of stroke care.
Understanding the ADAPT 2.0 Clinical Study
The ADAPT 2.0 Clinical Study is a prospective, multi-center, open-label, observational trial designed to assess the safety, effectiveness, and clinical outcomes of a next-generation thrombectomy approach. This study builds upon the established ADAPT (A Direct Aspiration First Pass Technique) method, which has already gained recognition as a frontline treatment strategy in acute ischemic stroke.
The trial is expected to enroll up to 750 patients across approximately 50 clinical sites throughout the United States. By involving a large and diverse patient population, the study aims to generate robust, real-world evidence that reflects everyday clinical practice rather than controlled experimental conditions.
Participants in the study will undergo treatment using the Zoom Stroke System, which enables the ADAPT 2.0 technique. Patients will be followed for a period of 90 days after the procedure, allowing researchers to evaluate both immediate procedural success and longer-term recovery outcomes.
The Role of the Zoom Stroke System in Treatment
At the core of this study is the Zoom Stroke System, an advanced medical device engineered to facilitate aspiration thrombectomy—a minimally invasive procedure used to remove blood clots from blocked arteries in the brain.
The ADAPT 2.0 technique leverages several key innovations enabled by this system:
- Closer Catheter Placement: A large-bore intracranial catheter (0.088”) is delivered closer to the clot, improving the likelihood of effective removal.
- Asymmetric Tip Design: The catheter features a specially designed tip that enhances clot ingestion, increasing the chances of complete removal in a single attempt.
- Continuous Dual Aspiration Technique (CDAT): This method ensures consistent suction during the procedure, potentially improving clot retrieval efficiency and reducing complications.
These enhancements are intended to simplify the thrombectomy workflow while improving clinical outcomes, making the procedure more predictable and efficient for physicians.
Key Objectives and Clinical Endpoints
The ADAPT 2.0 study is structured around clearly defined clinical endpoints that measure both effectiveness and safety.
Primary Efficacy Endpoint:
The main measure of success is the proportion of patients achieving excellent reperfusion, defined as a modified Thrombolysis in Cerebral Infarction (mTICI) score of 2c or higher. This indicates near-complete restoration of blood flow to the affected area of the brain.
Primary Safety Endpoint:
The study also closely monitors the occurrence of Embolization to New Territory (ENT), a complication in which fragments of a clot travel to previously unaffected blood vessels, potentially causing additional damage.
By focusing on these endpoints, researchers aim to determine whether the ADAPT 2.0 technique can deliver both high success rates and a strong safety profile.
Importance of Procedure Time in Stroke Outcomes
One of the key motivations behind the ADAPT 2.0 study is the growing recognition that procedure time plays a critical role in patient outcomes. Faster restoration of blood flow—often summarized by the phrase “time is brain”—is directly associated with improved neurological recovery and reduced long-term disability.
David Fiorella, M.D., Ph.D., Clinical Professor of Neurological Surgery at Stony Brook Medicine, emphasized the importance of this factor. According to him, recent research suggests that the total time required to complete a thrombectomy procedure may be an even stronger predictor of patient outcomes than achieving clot removal on the first attempt.
The ADAPT 2.0 technique is specifically designed to reduce procedural complexity and time to final reperfusion, potentially leading to better recovery trajectories for patients.
A System-Based Approach to Stroke Intervention
Unlike traditional methods that focus on individual tools or steps, the ADAPT 2.0 technique represents a comprehensive, system-based approach to stroke care. By integrating device design, procedural strategy, and workflow optimization, the technique aims to deliver consistent and reproducible results across different clinical settings.
Emir Deljkich, Senior Vice President of Clinical Affairs at Imperative Care, highlighted that the study builds on the success of earlier trials and aims to evaluate the real-world performance of these innovations. He noted that the approach incorporates multiple procedural improvements intended to streamline thrombectomy and support better patient outcomes.
This holistic strategy could help standardize stroke treatment protocols and reduce variability in care, which is a key challenge in current clinical practice.
Leadership and Collaboration Across Institution
The ADAPT 2.0 study is co-led by a team of nationally recognized experts in neurointervention and stroke care. These principal investigators bring extensive clinical experience and research expertise to the trial, ensuring rigorous study design and execution.
The leadership team includes:
- David Fiorella – Stony Brook Medicine
- Shahram Majidi – Icahn School of Medicine at Mount Sinai
- Justin Mascitelli – UT Health San Antonio
- Max Mokin – University of South Florida
This multi-institutional collaboration underscores the importance of collective expertise in advancing stroke treatment and generating high-quality clinical evidence.
Building on the Legacy of ADAPT
The original ADAPT technique has already transformed the field of thrombectomy by demonstrating the clinical value of direct aspiration as a first-line treatment strategy. It has become widely adopted and is considered a standard of care in many institutions.
ADAPT 2.0 builds on this foundation by introducing refinements that address limitations in the original approach. These enhancements are designed to improve consistency, reduce procedure time, and increase the likelihood of successful outcomes.
By evaluating these improvements in a large-scale clinical study, Imperative Care aims to further validate and expand the role of aspiration-based techniques in stroke intervention.
Potential Impact on Patient Care
If successful, the ADAPT 2.0 study could have far-reaching implications for the treatment of acute ischemic stroke. The combination of faster procedures, simplified workflows, and improved reperfusion rates could lead to:
- Better neurological recovery for patients
- Reduced long-term disability
- Shorter hospital stays
- Lower healthcare costs
Moreover, the availability of real-world, independently adjudicated data will provide clinicians with valuable insights into the effectiveness of this approach across diverse patient populations.
The initiation of the ADAPT 2.0 Clinical Study marks an important milestone in the evolution of stroke care. By combining innovative technology with a streamlined procedural approach, Imperative Care is aiming to redefine how acute ischemic stroke is treated.
As the study progresses and more data becomes available, the medical community will gain a clearer understanding of how these advancements can be integrated into clinical practice. Ultimately, the goal is to improve patient outcomes and provide more efficient, reliable treatment options for one of the most time-sensitive medical emergencies.
With strong leadership, a robust study design, and a focus on real-world application, ADAPT 2.0 has the potential to play a pivotal role in shaping the future of stroke intervention.
About Imperative Care, Inc.
Imperative Care is a commercial-stage medical technology company focused on advancing treatments for patients suffering from thromboembolic disease, a serious medical condition caused by blood clot formation inside veins and arteries. Imperative Care was founded with the mission of bringing lifesaving treatments to patients suffering from ischemic stroke and other devastating vascular diseases caused by blood clot formation. The company’s commercially available product portfolio includes the Zoom Stroke System, the Symphony Thrombectomy System and the Prodigy Thrombectomy System. In addition to our commercial products, we are developing the Telos robotic platform*, an endovascular robotic system designed to bring greater precision and standardization to procedures and expand access to lifesaving treatment. Imperative Care is based in Campbell
