Imperative
Trial
Study Objective
To assess the safety and efficacy of the Zoom System, including aspiration with 0.088” ID catheters, within 8 hours of last known well.
Prospective,
Consent Before Groin Puncture
26 Hospitals with Patients Enrolled
211 Patients with Concomitant Aspiration1
0.088” Aspiration Indication as part of the Zoom System
Trial Results
19
Minutes
Median groin puncture to mTICI2b+2
Fastest time to reperfusion of major prospective MT trial3
4.7%
Rescue device rate
Rescue device rate to achieve 91% final reperfusion (mTICI2b+)2, 4
Lowest rescue device rate of major prospective MT trials⁵
26%
Type 3 arches6
Encompassed significantly more type 3 arches than real-world anatomy⁷
Excellent Safety Profile
0.5%
Serious vessel injury2
0.9%
sICH2
M2 Cohort Results8
The Imperative Trial has shown excellent results, including unparalleled safety in M2 occlusions.
69
Age, median
55.5%
mRS 0-1
13
Baseline
NIHSS, median
1.5%
sICH
87.7%
Core-lab final
TICI ≥ 2B*
Note: individual trials are not directly comparable and data is presented for observational purposes only.
- Total study population = 260 patients. Results presented include concomitant cohort only. Per IFU: when using the LDP Catheter, the LDP Catheter must be used in conjunction with a Zoom Catheter.
- Zoom System IFU (LBL002069.A), n=211
- Major MT trials with reperfusion times reported: ARISE II, TIGER, PROST, PENUMBRA 3D, ASTER, COMPASS, DEFUSE 3, DAWN
- IMPERATIVE Trial data cohort analysis, n=211
- Major MT trials with rescue rates reported: Compared to: ASTER, COMPASS, ARISE II, TIGER, PROST
- IMPERATIVE Trial data concomitant aspiration cohort analysis (arch type available for n=158 subjects of cohort).
- Mokin et al. “Semi-automated measurement of vascular tortuosity and its implications for mechanical thrombectomy performance.” Neuroradiology vol. 63,3 (2021): 381-389.
- IMPERATIVE Trial data cohort analysis, n=65
*At the end of procedure