STRIKE-PE Study

A Prospective, Multicenter Study of the Indigo® Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

Prospective, Single-Arm

Up To 600 Patients

Global Multicenter Study

Acute Intermediate and High-Risk PE

  • Evaluate real-world long-term functional outcomes, safety, and performance of the Indigo Aspiration System for the treatment of PE.

  • Per the interim results, treatment with CAVT showed significant improvement in primary safety and efficacy endpoints and disease-specific and generic QoL measures.

ClinicalTrials.gov Study Site

Interim Results (N = 150):1

Rapid, statistically significant improvements in RV/LV ratio and sPAP while maintaining safety

RV/LV Ratio Improvement

25.7%

(0.38)

sPAP Improvement

16.3%

(8.9 mmHG)

Low Composite MAE Rate

2.7%

(4/150)

Treatment with Computer Assisted Vacuum Thrombectomy (CAVT) improved both generic and disease-specific QoL measures

  • EQ-5D-5L

    ✔️Improvement

  • EQ-5D-5L
    Index Value

    ✔️Improvement

  • EQ VAS

    ✔️Improvement

  • PEmb-QoL
    Overall

    ✔️Improvement

Lightning Flash Subset Analysis (N = 42)2

Median Thrombectomy Timea

24.5 min

[19.0-36.0]

% Reduction in RV/LV
ratio

27.0%

(0.36)b

Composite MAE
Rate

2.4%

(1/42)c

a. First Indigo device insertion to last Indigo device removal.
b. N=41.
c. Access site hematoma.

1. Weinberg I. Acute clinical and 90-day functional outcomes in pulmonary embolism patients treated with computer assisted vacuum thrombectomy: interim analysis of the STRIKE-PE study. Presented at: VIVA (Vascular InterVentional Advances) 2023; 01 November 2023; Las Vegas, NV.
2. Moriarty JM. Safety, performance, and quality of life outcomes in pulmonary embolism patients treated with computer-aided thrombectomy: real-world 90-day outcomes from the STRIKE-PE study. Presented at: PERT 2023; 21 September 2023; Austin, TX.

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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