Post-marketing study of patients to evaluate NIMBUS revascularization effectiveness with challenging occlusions...

The NIMBUS geometric clot extractor was specifically developed for fibrin-rich tough clots that are difficult to remove using standard mechanical thrombectomy (MT) techniques.

To evaluate the use of NIMBUS in real-world patients with challenging clots and analyze their composition.

SPERO is a prospective, multicenter, single-arm, observational post-market study that enrolled patients at 11 European sites. Patients presenting with acute ischemic stroke due to large vessel occlusion underwent MT using NIMBUS after one or two failed attempts using another stent retriever or aspiration device. The primary endpoint was successful revascularization (modified Thrombolysis in Cerebral Infarction (mTICI)≥2b) after the final pass of NIMBUS. Additional revascularization, clinical, and clot composition endpoints were collected and assessed by an independent imaging and central clot core lab.

Between October 2019 and February 2022, NIMBUS was used in 54 patients after an average of 1.8 failed MT passes. First pass recanalization (mTICI≥2b) with NIMBUS occurred in 52.9% (27/51) of patients, final NIMBUS pass with mTICI≥2b in 68.6% (35/51), and final procedural mTICI≥2b including all post-NIMBUS rescue maneuvers in 79.2% (42/53). Embolization in new territory was not observed, symptomatic intracerebral hemorrhage occurred in 3.7% (2/54), mortality was 18.5% (10/54), and 90-day mRS score ≤2 was 38.9% (21/54). NIMBUS productivity was higher than as for non-NIMBUS devices, with fibrin content (40.3% vs 29.5%).

In real-world challenging MT cases, NIMBUS demonstrated consistent ability to achieve revascularization in challenging patients for whom 1-2 conventional device passes had failed. Clot composition analysis confirmed that NIMBUS retrieved tougher clots compared with the general stroke population.

www.

gov Unique identifier: NCT03898960.