SMH Joins Multi-Center Trial

January 17, 2024 – Sarasota

Sarasota Memorial is joining up to 40 other research sites across the nation testing a new, endovascular  option for patients with deep vein thrombosis (DVT), a complicated condition that endangers nearly 1 million people in the U.S. each year.

DVT occurs when blood clots develop in the deep veins of the body, usually in the leg. DVTs can become deadly when blood clots break loose and become lodged in the lung, a life-threatening complication known as a pulmonary embolism (PE). DVT/PE is the third most common vascular disease, behind heart attacks and strokes, and kills as many as 300,000 people in the U.S. each year.

Vascular surgeon Jason Wagner, MD, principal investigator of Penumbra’s multi-center BOLT study at SMH, said the clinical trial will assess the safety and effectiveness of treating DVT with the Indigo® Aspiration System used to perform Computer Assisted Vacuum Thrombectomy (CAVT). This catheter-based endovascular system uses computer-assisted technology to accelerate clot detection and remove clot using a dedicated aspiration pump, aimed to complete procedures in a single session, without the need for clot-dissolving medications or open surgery.

“DVTs can pose significant risks, including fatal complications such as pulmonary embolism, if left untreated,” said Dr. Wagner. “Advances like Penumbra’s Indigo Aspiration System provide another way to address and remove dangerous clots through CAVT before they can trigger a life-threatening event.”

Adults experiencing their first episode of unilateral lower extremity DVT, and who are symptomatic for 14 days or less, are eligible to enroll in the study. For information about the trial and enrollment criteria, call Sarasota Memorial’s Research Institute at (941) 917-2225 or visit the FDA clinical trial webpage at: https://clinicaltrials.gov/ct2/show/NCT05003843.