Penumbra today announced that the first patient has been enrolled in STORM-PE, a prospective, multicentre, randomised controlled trial (RCT) evaluating anticoagulation alone versus anticoagulation plus Lightning Flash for the treatment of pulmonary embolism (PE).
In partnership with PERT Consortium, a multidisciplinary group dedicated to improving the care of patients with PE, the STORM-PE trial aims to advance the understanding of the role of computer-assisted vacuum thrombectomy (CAVT) in the management of acute PE, with a goal of improving the outcomes for patients with this condition.
“STORM-PE is the first head-to-head trial comparing anticoagulation, the mainstay and standard of care for treating acute PE, to CAVT,” said Rachel Rosovsky (Massachusetts General Hospital, Boston, USA), co-global principal investigator of STORM-PE. “We have already seen the significant impact Lightning Flash can have on patients. The results generated from this pivotal RCT study will provide level 1 evidence of how CAVT compares to current treatment paradigms and will inform us if treatment guidelines need to include this technology as a frontline therapeutic option in patients with intermediate high-risk PE.”
STORM-PE will enrol up to 100 participants at up to 20 sites. Penumbra’s Lightning Flash can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems and can be used for the treatment of PE. A press release details that Lightning Flash combines hypotube-based Indigo Aspiration Catheters with Lightning Intelligent Aspiration, a computer-assisted clot detection technology that can differentiate between clot and blood, designed to reduce blood loss and the need for clot-dissolving drugs, which may lower the risk of bleeding complications.
“Enrolling the first patient in STORM-PE RCT is an important milestone,” said Nicolas J Mouawad (McLaren Health Care, Bay City, USA). “This landmark RCT will be instrumental to advancing the standard of care for patients with [PE].”
“Endovascular therapy has been shown to be an increasingly safe and effective treatment for patients with a symptomatic acute [PE],” said Robert Lookstein (Icahn School of Medicine at Mount Sinai, New York, USA), co-global principal investigator. “We are proud to commence enrolment in the STORM-PE trial. This trial is designed to answer whether CAVT plus anticoagulation can restore normal function to the failing right ventricle faster and more reliably than anticoagulation alone. We are confident this trial will generate foundational data leading to the next generation of randomised studies in the field of venous thromboembolism for years to come.”
“Our commitment to clinical research and innovation enables us to lead with insight and continue to pioneer interventional therapies that have a significant impact on patients such as our CAVT technologies,” said James F Benenati, chief medical officer at Penumbra. “In partnership with PERT Consortium, we are committed to generating robust clinical evidence that will help transform care so patients, especially those with serious conditions such as PE, can return home quickly and live fully.”