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 1500 Patients
(Expanded from 600 to 1500 patients in July 2024)
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 = 300):1
Rapid, statistically significant improvements in RV/LV ratio and sPAP while maintaining safety
RV/LV Ratio Improvement
26.8%
(0.40)
sPAP Improvement
19.1%
(10.4 mmHg)
Low Composite MAE Rate
2.0%
(6/300)
Treatment with Computer Assisted Vacuum Thrombectomy (CAVT) improved both generic and disease-specific QoL measures2
EQ-5D-5L
✔️Improvement
EQ-5D-5L
Index Value
✔️Improvement
EQ VAS
✔️Improvement
PEmb-QoL Overall
✔️Improvement
Lightning Flash Subset Analysis (N = 86)1, 3
Median Thrombectomy
Timea
23.0 min
[19.0-35.0]
RV/LV Ratio
Improvement
27.8%
(0.40)b
Composite MAE
Ratec
1.2%
(1/86)d
Transfusion Required
before Discharge
0
a. First Indigo device insertion to last Indigo device removal.
b. N=83.
c. No device-related serious adverse events
d. Access site hematoma.
1. Moriarty, J. M. Periprocedural Results of an Interim Analysis of 300 Pulmonary Embolism Patients From the STRIKE-PE Study. Presented at PERT 2024, September 2024
2. Moriarty JM, Dohad SY, Schiro BJ, Tamaddon H, Heithaus RE, Iliadis EA, Dexter II DJ, Shavelle DM, Leal SRN, Attallah A, West FM, Keeling WB, Sharp AS, Weinberg I, Clinical, Functional, and Quality of Life Outcomes after Computer Assisted Vacuum Thrombectomy for Pulmonary Embolism: Interim Analysis of the STRIKE-PE Study, Journal of Vascular and Interventional Radiology (2024), doi: https://doi.org/10.1016/j.jvir.2024.04.028.
3. Qanadli S. Periprocedural outcomes of pulmonary embolism patients treated with computer assisted vacuum thrombectomy: interim analysis of the STRIKE-PE study. Presented at: CIRSE 2024; September 2024
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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