Penumbra’s Indigo System Studied in STRIDE to Treat Lower Extremity Acute Limb Ischemia

November 4, 2022—The global, prospective, multicenter STRIDE study is investigating the safety and performance of the Indigo aspiration system (Penumbra, Inc.) for the treatment of lower extremity acute limb ischemia (LE-ALI). The study is designed to enroll up to 130 participants presenting with LE-ALI who are treated with frontline aspiration thrombectomy using Indigo aspiration before stenting or angioplasty.

Thomas Maldonado, MD, presented an interim analysis of the STRIDE safety and performance data during the second of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

According to the VIVA Foundation press release, the STRIDE primary endpoint is the target limb salvage rate at 30 days postprocedure. Secondary endpoints include technical success (defined by core lab–adjudicated thrombolysis in myocardial infarction [TIMI] 2/3 flow rate immediately postprocedure) and change in modified Society for Vascular Surgery (SVS) runoff score.

In the analysis of 96 patients enrolled at 14 sites, the mean age was 65.9 years (46.9% female).

Ischemic severity at baseline (n = 95) was classified as Rutherford class 1 in 5.3% of patients, Rutherford class 2a in 57.9% of patients, and Rutherford class 2b in 36.8% of patients.

Mean thrombus length was 109.9 ± 115.8 mm. Before the procedure, 94.5% of patients (69/73) had no flow (TIMI 0) through the target lesion. The most common thrombus location was the popliteal in 66.0% of patients (62/94), followed by the superficial femoral in 44.7% (42/94).

Dr. Maldonado reported that the target limb salvage rate at 30 days was 97.9% (94/96). The rate of periprocedural major bleeding was 4.2%, and device-related serious adverse events was 1.0%. Flow restoration (TIMI 2/3) was achieved in 94.4% (67/71) of patients immediately postprocedure. Median improvement of modified SVS runoff score (after vs before procedure) was 5.0 (0.0, 10.0).

In this interim analysis, STRIDE patients treated with Indigo aspiration had low 30-day amputation rates, low periprocedural complications, and high rates of technical success. Mechanical aspiration thrombectomy provided an effective endovascular treatment option in this population of LE-ALI patients, noted the VIVA Foundation press release.