CathWorks Completes Enrollment for Transformative Cardiovascular Study

CathWorks Marks a Milestone in Cardiovascular Research

CathWorks, a global front-runner in digital health innovations for medical devices, has achieved a significant milestone with the completion of enrollment for the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment (ALL-RISE) randomized controlled trial (RCT). This pivotal research aims to explore the potential clinical and economic advantages of the CathWorks FFRangio System in tackling coronary artery disease (CAD).

The ALL-RISE Trial Overview

The ALL-RISE Study has engaged over 1,924 patients across 59 sites internationally. The participants included individuals with coronary stenoses of intermediate severity who required physiological assessment. They were allocated randomly to undergo either FFRangio-guided treatment or traditional invasive pressure wire-guided treatment. This study is a groundbreaking endeavor, as it marks the first randomized controlled trial of its kind within the U.S. focused on evaluating clinical results using angiography-based tools for physiological lesion assessment.

Insights from Leadership

In a collective statement, Dr. Ajay J. Kirtane, the chair of the ALL-RISE Study from NewYork-Presbyterian/Columbia University Irving Medical Center, together with principal investigators Dr. William Fearon from Stanford University and Dr. Allen Jeremias of St. Francis Hospital & Heart Center, expressed their gratitude to all global investigators, coordinators, and participants. They noted, "This accomplishment reflects the dedication of many individuals, and the swift enrollment process corroborates the growing global acceptance of FFRangio technology. We are eager to share the findings of this important study following the completion of clinical follow-ups."

Implications for Cardiac Care

CathWorks' Senior Director of Clinical Affairs, Dr. Alex Froimovich, articulated that completing the ALL-RISE enrollment signifies a noteworthy moment for their team. He emphasized, "This study could dramatically influence the landscape of coronary physiology, underscoring the need for evidence-based clinical approaches when measuring FFR values. The FFRangio System stands out for its diagnostic accuracy compared to other angiography-based technologies, emphasizing the necessity for technology-specific clinical data. These advancements could bridge the gap between the current rate of adoption and established medical guidelines."

The Wider Impact of Cardiovascular Diseases

Cardiovascular disease (CVD) remains the foremost cause of mortality in many regions. The American Heart Association's recent statistics reveal alarming numbers, with CVD responsible for a staggering 931,578 deaths in the U.S. alone in a recent year, accounting for a significant fraction of global fatalities. Among CVDs, coronary artery disease (CAD) represents the highest percentage of these deaths.

About CathWorks

CathWorks is a leader in pioneering digital health technologies aimed at improving patient outcomes worldwide. The FFRangio System, integrated with artificial intelligence and advanced computational methodologies, revolutionizes the diagnosis and management of cardiovascular conditions. It extracts vital physiological data from routine angiograms without the need for invasive procedures, thus offering a fast and reliable alternative for evaluating the entire coronary artery system.

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Frequently Asked Questions

What is the main objective of the ALL-RISE study?

The primary goal is to evaluate the clinical and economic impacts of the FFRangio System in treating coronary artery disease.

How many patients were involved in the ALL-RISE trial?

Approximately 1,924 patients participated across 59 study sites worldwide.

What innovative technology does CathWorks utilize?

CathWorks uses the FFRangio System, which leverages artificial intelligence to extract physiological metrics from angiography.

Why is this study significant for healthcare?

This research may enhance how coronary artery disease is diagnosed and treated, providing support for improved patient outcomes.

Who are the key people involved in the ALL-RISE study?

Prominent figures include Dr. Ajay J. Kirtane, Dr. William Fearon, and Dr. Allen Jeremias, who serve as pivotal leaders throughout the trial.

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