STRIDE Study
Firstline use of the Indigo® Aspiration System for Acute Limb Ischemia patients resulted in low 30-day amputation rates, low peri-procedural complications, and high rates of technical success.
Prospective, Single-Arm
119 Patients
16 International Sites
Lower Extremity Acute Limb Ischemia (LE-ALI)
To collect safety and performance data with the Indigo Aspiration System in a patient population with lower extremity acute limb ischemia (LE-ALI)
In the STRIDE study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for LE-ALI patients, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few peri-procedural complications.
Now published in the Journal of Vascular Surgery
Clinical Trials
STRIDE II Now Enrolling
30-day Results:
98.2%
Target limb salvage rate at 30 days post procedure
3.4%
Mortality at 30 days
22 min
Median Indigo Aspiration Time
0.8%
Device-related SAE
Historical Surgical Outcomes & STRIDE Study Data
| Outcome | Open Surgery | STRIDE1,a |
| Target Limb Salvage at 30 days | 83.1%2,b | 98.2% (109/111) |
| Patency at 30 days | 78.6%3 | 89.4% (101/113) |
| Mortality at 30 days | 13.2%4 | 3.4% (4/119) |
| Major bleedingc | 21.0%5 | 4.2% (5/119) |
Follow up clinical trial now underway — STRIDE II
STRIDE II is a prospective clinical study incorporating the latest Lightning Bolt technology. The trial has initiated enrollment and will activate up to 50 sites globally, with a target of up to 300 treated limbs. Compared to its predecessor, STRIDE II will more than double the number of limbs treated and expand the range of vessel locations, including iliac arteries and below. Participants will be followed for up to 180 days post-treatment. Please see the link for additional information found on ClinicalTrials.gov
a. STRIDE study was not a randomized or head-to head study; data cannot be directly compared. Please refer to specific publications to review source for detailed patient and data collection methods for open surgical revascularization.
b. Composite limb salvage rate at 30 days calculated and data on file at Penumbra, Inc.
c. Major bleeding definitions may vary across studies. Please refer to specific publications for details.
1. Maldonado TS, Powell A, Wendorff H, et al. Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia. J Vasc Surg. 2024;79(3):584–592.e5. doi:10.1016/j.jvs.2023.10.062.
2. Veenstra EB, van der Laan MJ. Zeebregts CJ, et al. A systematic review and meta-analysis of endovascular and surgical revascularization techniques in acute limb ischemia. J Vasc Surg. 2020 Feb;71(2):654-668.e3. doi:10.1016/j.jvs.2019.05.031.
3. Grip O. Wanhainen A, Michaëlsson K, Lindhagen L, Björc M. Open or endovascular revascularization in the treatment of acute lower limb ischaemia. Br J Surg. 2018 Nov;105(12):1598-1606. doi:10.1002/bjs.10954.
4. Taha AG, Byrne RM, Avgerinos ED, et al. Comparative effectiveness of endovascular versus surgical revascularization for acute lower extremity ischemia. J Vasc Surg. 2015 Jan;61(1):147-157. doi:10.1016/j.jvs.2014.06.109.
5. Kolte D, Kennedy KF, Shishehbor MH, et al. Endovascular versus surgical revascularization for acute limb ischemia: a propensity-score matched analysis. Circ Cardiovasc Interv. 2020;13(1):e008150.
The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors.
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