One-year limb salvage and quality of life (QoL) data from the STRIDE study, showing that frontline use of Penumbra’s Indigo system for patients with lower extremity acute limb ischaemia (LE-ALI) is safe and effective, has been published in the Journal of Vascular Surgery. Results were presented at the Vascular Annual Meeting (VAM 2024; 19–22 June, Chicago, USA).
One-year outcomes include: 88.5% target limb salvage rate and 12% mortality rate at 365 days, and overall improvement in QoL, as measured by the VascuQoL-6 questionnaire, from baseline to one year follow-up.
The latest results build on evidence from the initial publication of 30-day STRIDE data, in which the primary endpoint, target limb salvage, was achieved in 98% of patients. The Indigo system was able to achieve these high rates of limb salvage and low rate of mortality with median device time of 22 minutes.
“The latest STRIDE data continue to demonstrate the use of Penumbra’s Indigo aspiration system to address LE-ALI results in excellent outcomes, including high target limb salvage rates and quality of life,” said Thomas Maldonado (New York University of Langone Health, New York, USA), national principal investigator of the STRIDE study. “The data is promising in that it underscores the significant benefits of continuous aspiration to remove thrombus and should be considered a frontline treatment for LE-ALI.”
STRIDE was a multicentere, prospective, single-arm, observational study that enrolled 119 patients across 16 sites in the USA and Europe. The study, which completed follow-up in October 2023, was designed to assess safety and efficacy of mechanical thrombectomy using the Indigo aspiration system in patients with LE-ALI. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centred QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days.
ALI, a sudden lack of blood flow to a limb, is associated with a high risk of amputation and death. Early diagnosis and intervention are crucial to improving patient outcomes and preserving limb function. Penumbra’s Indigo aspiration system is a minimally invasive continuous aspiration device that is designed to quickly remove emboli and thrombi from vessels of the peripheral arterial and venous systems.
