4-NiVO Trial Begins for iVascular’s iNstroke 4F Thromboaspiration Catheter

December 22, 2025—iVascular announced the initiation of the 4-NiVO clinical study, which is evaluating the efficacy and safety of its iNstroke 4F thromboaspiration catheter in acute ischemic stroke patients with distal medium vessel occlusions who are treated within 24 hours from symptom onset.

iVascular stated that the iNstroke 4F device is a new-generation distal aspiration catheter developed for the removal of thrombi located beyond M2 segments and in highly tortuous anatomy.

The first patient in the study was enrolled by the team of Sandor Nardai, MD, at H. Semmelweis University Center of Neurosurgery and Neurointervention in Budapest, Hungary.

According to the company, 4-NiVO is a prospective, multicenter, single-arm study that will enroll 57 patients over 6 months, with follow-up at 24 hours, 72 hours, and 90 days after the procedure. The Principal Investigator Coordinator of the study is Manuel Requena, MD, from Hospital Universitario Vall d’Hebrón in Barcelona, Spain.

As noted in the press release, the primary endpoint of the 4-NiVO study is the rate of successful recanalization modified thrombolysis in cerebral infarction (mTICI ≥ 2b) achieved within three or fewer passes using the iNstroke 4F catheter, alone or with a stent retriever.

Additionally, secondary endpoints include first-pass effect (mTICI ≥ 2b/≥ 2c/3), direct clot contact, and proportion of subjects achieving a modified Rankin Scale score of 0–2 at the 90-day (± 14 days) follow-up visit postprocedure.

The safety endpoints are composed rates of symptomatic intracranial hemorrhage, distal or new-territory embolization, device and procedure-related events, and in-hospital mortality, stated in iVascular.