Dr. William Mack, co-principal investigator, presented the results at the Society of NeuroInterventional Surgery (SNIS) annual meeting.
The study evaluated 260 patients across 26 U.S. institutions between October 2021 and March 2024. In total, 254 patients completed follow-up at 90 days. It looked at the Zoom reperfusion system, which included aspiration with 0.088” catheters.
Results demonstrated that 82.2% (213 patients) achieved the core-lab adjudicated rate of mTICI ≥2B reperfusion within ≤3 passes without the use of any additional thrombectomy devices as rescue therapy.
Imperative Care said in a news release that results proved similar to prior trial used to support FDA 510(k) clearance for reperfusion indications. Stent retrieval rescue therapy achieved mTICI ≥2B reperfusion in only 5.5% (13) of cases.
Data showed that the median time from groin puncture to reperfusion using Zoom totaled 19 minutes. Investigators reported a 2.3 rate of symptomatic intracranial hemorrhage, lower than the rate of prior trials. The rate of independently adjudicated dissection and vessel perforation came in at 1.2%, again proving similar to prior trials.
According to Mack, the study met all three pre-specified performance goals with these results. He called the low rate of hemorrhage with high rates of reperfusion “promising.”
“We are pleased with the preliminary results of the Imperative trial,” said Fred Khosravi, chair and CEO of Imperative Care. “Our mission to elevate care for patients suffering from stroke and other devastating vascular diseases extends beyond the operating room. We are happy to advance the field through our commitment to validating our innovations with robust clinical data.”
