Imperative Care Study Aims to Set New Standard for Clot Removal

CAMPBELL, CA – March 25, 2026 – By Stephanie Lewis

Medical technology firm Imperative Care has launched a major clinical study that aims to establish clear, evidence-based standards for treating dangerous blood clots in the body’s extremities and lungs, a field where rapid technological adoption has outpaced clinical consensus.

The company announced the enrollment of the first patient in the CLEAR-IT study, a large-scale, real-world evaluation of its Symphony and Prodigy thrombectomy systems. The study will track up to 750 patients across the United States, gathering crucial data on procedures for pulmonary embolism, deep vein thrombosis, and peripheral arterial blockages.

Bridging a Critical Gap in Vascular Medicine

Peripheral thromboembolic diseases, which involve blood clots obstructing arteries or veins outside the brain and heart, pose serious risks including limb loss and death. While anticoagulants, or blood thinners, have long been the cornerstone of treatment, they are not always sufficient. They can fail to dissolve large clots, leading to long-term complications like post-thrombotic syndrome, and they carry a persistent risk of bleeding.

In recent years, minimally invasive endovascular procedures have surged in popularity. Medicare data reveals a staggering 712% increase in thrombectomies for pulmonary embolism (PE) and a 137% rise for deep vein thrombosis (DVT) between 2017 and 2022. This rapid adoption highlights a pressing clinical need, yet it has also exposed a "substantial paucity of literature," as noted in recent cardiovascular research, creating a critical gap between practice and evidence.

"CLEAR-IT is designed to evaluate how Symphony and Prodigy perform across a broad range of peripheral thromboembolic conditions in real-world clinical practice,” said Dr. Steven Abramowitz, Chief of Vascular Surgery at MedStar Hospital and a co-leader of the study, in a statement. He emphasized the study's structure is intended "to drive clinically meaningful endpoints that matter to physicians and patients." By generating this high-quality data, the study aims to move the field closer to establishing clear clinical standards for each of these distinct diseases.

Aspiration Technology at the Forefront

At the heart of the CLEAR-IT study are Imperative Care's two distinct aspiration-based thrombectomy systems. Unlike traditional methods that may rely on clot-dissolving drugs (thrombolysis) delivered throughout the body or via a catheter, aspiration thrombectomy works like a sophisticated vacuum to actively pull the clot material out of the vessel. This approach has the potential to restore blood flow more quickly while minimizing the bleeding risks associated with thrombolytic agents.

The Symphony Thrombectomy System, a large-bore device, is engineered for use in the venous system, tackling conditions like DVT and PE. It is designed to combine powerful suction with precise control to remove large clot burdens efficiently. The Prodigy Thrombectomy System is its smaller-bore counterpart, optimized for the more delicate and varied anatomy of the peripheral arteries in the arms and legs.

The potential of this technology has already been suggested in earlier trials. "Following the SYMPHONY-PE investigational device exemption trial, which demonstrated favorable safety and efficacy results, initial real-world experience with this technology has shown fast, effective clot removal with minimal blood loss," stated Dr. Dana Tomalty of Huntsville Hospital Health System, who treated the first patient enrolled in the new study. The CLEAR-IT study is poised to build on these initial findings with a much larger and more diverse patient population.

A Strategic Play in a Competitive Med-Tech Arena

The launch of the CLEAR-IT study is not just a clinical milestone but also a significant strategic maneuver for Imperative Care. The thrombectomy device market is a dynamic and competitive space, with established players like Inari Medical and Penumbra also offering advanced solutions for clot removal. In this environment, robust clinical evidence is the ultimate currency for differentiation and market leadership.

By investing in a large-scale, prospective study, Imperative Care is following a playbook that proved successful in the stroke field, where its "Imperative Trial" helped establish new standards of care. The company is betting that generating definitive data on safety, efficacy, and patient outcomes will be the key to convincing physicians, hospitals, and insurance payers of its technology's value.

Positive results could have a cascading effect. They could directly influence the guidelines issued by major medical societies like the American Heart Association and the Society of Interventional Radiology, elevating the role of aspiration thrombectomy. This, in turn, would strengthen the case for consistent insurance reimbursement, making the technology more accessible to patients. For investors, a successful trial validates the company's product pipeline and its evidence-driven market strategy, potentially solidifying its position as a key innovator in vascular disease treatment.

Real-World Data for Real-World Problems

The CLEAR-IT study is designed as a prospective, observational trial, meaning it will follow patients undergoing treatment in routine clinical settings rather than under the highly controlled, and sometimes artificial, conditions of a randomized controlled trial. This approach is intended to capture how the Symphony and Prodigy systems perform in the hands of various physicians on a wide spectrum of patients and clot types.

The study, co-led by Dr. Abramowitz and Dr. Maya Serhal, an interventional cardiologist at Massachusetts General Hospital, will enroll patients at up to 50 sites across the U.S. This broad footprint will help ensure the findings are generalizable to the diverse American patient population. The long-term follow-up component is also critical, as it will provide insights into the durability of the treatment and its impact on preventing long-term complications.

For the physicians on the front lines, the data from CLEAR-IT could be transformative. It promises to provide the evidence needed to make more informed decisions, tailoring treatments to individual patients with greater confidence. As Dr. Tomalty noted, contributing to this body of "independently adjudicated clinical data" has the potential to "further advance the field and support more informed clinical decision-making for patients with thromboembolic disease." The study represents a concerted effort to replace anecdotal experience and fragmented data with a robust, shared understanding of the best ways to treat these common and life-threatening conditions.