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.
Want to Learn More?
Contact us to learn more about CAVT and schedule a demo