University of Minnesota leading in enrollments for EXTRACT-PE Trial on Removal of Submassive Pulmonary Emboli

Pictured: Clots that were removed with the the Indigo® Aspiration System.

The University of Minnesota is the number one enrolling site in the nation for the Extract PE clinical trial. Michael S. Rosenberg, MD, FSIR, Department of Radiology is the PI for the trial involving 25 sites across the US with a target of 150 treated cases.

“We are fortunate to be included in this trial with several other great centers across the country,” said Rosenberg.

The clinical trial, EXTRACT-PE: A Prospective, Multi-Center Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Submassive Pulmonary Embolism, is being conducted to assess the safety and efficacy of suction thrombectomy as a valid alternative to thrombolytic drugs for the removal of submassive pulmonary emboli. It is estimated that submassive PE’s account for 40% of the PE population. For patients that have an increased bleeding risk, due to comorbid conditions, there are not many valid treatment options available. The device under investigation could prove to fill the treatment gap for these individuals.

“We have identified an unexpected large number of patients that present with submassive pulmonary embolism within our health system,” says Dr. Rosenberg, “Our challenge is to determine the best treatment for this condition that not only provides immediate clinical improvement but also long-term benefit.”

Enrolled patients are followed for 30 days post-procedure. CTA imaging acquired pre-and post-treatment is used to assess changes of right heart strain (elevated RV/LV ratio), as well as changes in perfusion, and the patients are monitored for adverse events.

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