Penumbra Commences STRIDE II Study of Lightning Bolt CAVT to Treat Lower Extremity ALI

May 7, 2025—Penumbra announced that it will begin recruitment for the STRIDE II study of its Lightning Bolt computer-assisted vacuum thrombectomy (CAVT) technology, which uses modulated aspiration for removing clots.

According to the company, the prospective, multicenter, global clinical study will evaluate the safety and effectiveness of Lightning Bolt CAVT devices in patients with lower-extremity acute limb ischemia (ALI). The Lightning Bolt portfolio includes Lightning Bolt 6x with Trax, Lightning Bolt 7, and Lightning Bolt 12.

STRIDE II will enroll up to 300 adult patients at up to 50 global sites. Patients will be followed through 6 months postprocedure.

Compared to the first STRIDE study, STRIDE II will more than double the number of patients enrolled; approximately triple the number of sites reporting data; and be more inclusive in terms of vessel locations, including iliac arteries and below, noted the company.

Penumbra stated that the first STRIDE study was an international, multicenter, prospective, single-arm study in which 43.7% of cases involved the use of Lightning devices.

STRIDE showed that the use of Penumbra’s Indigo aspiration system in lower extremity ALI is safe and effective with a 30-day limb-salvage rate of 98.2% and a mortality rate of 3.4%. By comparison, data suggest that traditional open vascular surgery to perform an embolectomy has an 83% 30-day limb salvage rate, advised Penumbra in the press release.

“The first STRIDE study showed that the Indigo aspiration system, including CAVT technology, was safe and effective for managing arterial thrombus with high limb-salvage rates, very low adverse events, low risk of bleeding, low mortality, all while being extremely efficient with an average 22 minutes of device time,” commented Daniel Clair, MD, in the company’s press release. “STRIDE II will test the latest technology while expanding the sample size and geographic scope of the investigation on a wider set of cases.”

Dr. Clair is Professor and Chair of the Department of Vascular Surgery at Vanderbilt University Medical Center in Nashville, Tennessee.