Trial results for the Envi™-SR device in acute ischemic stroke were posted on 2026-04-27, revealing the termination of the study after enrolling 12 participants.
Background
Acute ischemic stroke occurs when a blood clot blocks blood flow to the brain, leading to rapid brain cell death. Endovascular thrombectomy, which involves mechanically removing the clot, is a standard treatment for eligible patients. The Envi™-SR device was being investigated as a potential tool for this procedure, aiming to compare its clinical outcomes and performance against existing FDA-cleared devices such as the Solitaire or Trevo Revascularization Devices.
Trial design
The Envi™-SR Randomized Controlled Trial (NCT05107206) was a study evaluating an endovascular treatment for Acute Ischemic Stroke. The trial, which was terminated, had an enrollment of 12 participants. It aimed to compare the Envi™-SR Thrombectomy Device against concurrent parallel control devices, specifically the Solitaire or Trevo Revascularization Device, which are currently cleared by the U.S. FDA for stroke treatment. The primary objective was to examine and compare clinical outcomes, as measured by Modified Rankin Scale (mRS) at 90 days (± 15 days) post treatment, and related performance characteristics.
Key results
The trial reported limited results from its 12 enrolled participants prior to termination:
- Primary Effectiveness Endpoint: Proportion of Subjects With Good Clinical Outcome Defined as Modified Rankin Score (mRS) of ≤2
- Envi™-SR Thrombectomy Device: 2 participants with mRS ≤2
- Solitaire or Trevo Revascularization Device: 1 participant with mRS ≤2
- Primary Safety Endpoint: Device-related or Procedure-related Symptomatic Intracranial Hemorrhage (sICH)
- Envi™-SR Thrombectomy Device: 0 Participants with sICH
- Solitaire or Trevo Revascularization Device: 0 Participants with sICH
- Secondary Effectiveness Endpoint: Proportion of Subjects With Early Response (NIHSS)
- Envi™-SR Thrombectomy Device: 4 Number Participants with Early Response
- Solitaire or Trevo Revascularization Device: 3 Number Participants with Early Response
- Secondary Effectiveness Endpoint: Proportion of Subjects Who Achieve Successful Reperfusion Measured Using eTICI
- Envi™-SR Thrombectomy Device: 6 Participants with eTICI ≥2b50
- Solitaire or Trevo Revascularization Device: 5 Participants with eTICI ≥2b50
- Secondary Effectiveness Endpoint: Proportion of Subjects Achieving First Pass Effect (FPE)
- Envi™-SR Thrombectomy Device: 3 Participants achieving FPE
- Solitaire or Trevo Revascularization Device: 1 Participant achieving FPE
What this means
The termination of the Envi™-SR trial after enrolling only 12 participants means that the reported results are based on a very small sample size and cannot be considered definitive. While the Envi™-SR device showed numerically higher counts in some effectiveness endpoints, such as 2 participants with a good clinical outcome (mRS ≤2) compared to 1 in the control group, and 3 participants achieving First Pass Effect compared to 1 in the control group, these differences are based on extremely limited data. Both groups reported 0 participants with symptomatic intracranial hemorrhage, suggesting a similar safety profile within this small cohort. Due to the early termination and low enrollment, no robust conclusions can be drawn regarding the comparative efficacy or safety of the Envi™-SR device against established treatments for acute ischemic stroke.
Source
The information for this condition update was sourced from ClinicalTrials.gov, a public database of clinical studies. The trial results for NCT05107206, titled "Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke", were posted on 2026-04-27 on clinicaltrials.gov.