NCT05893719

Prospective, Multicentre Study to Evaluate the Thrombectomy System for Stroke: iNedit, iNdeep and iNtercept

First Prospective, Single-arm, Multicentre Study to Evaluate the Safety and Efficacy of the Overall Thrombectomy System for Stroke: iNedit, iNdeep and iNtercept in Patients With Acute Ischemic Stroke.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 175 (actual)
• Sponsor: iVascular S.L.U. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

First prospective, single-arm, multicentre study to evaluate the safety and efficacy of the overall stroke thrombectomy system: iNedit, iNdeep and iNtercept in patients with acute ischemic stroke.

Detailed description

This is a prospective, multicentre, single-arm and open-label clinical safety and efficacy research. The purpose of the study is to evaluate the safety and efficacy of the three devices designed by iVascular for neurothrombectomy (iNedit, iNdeep and iNtercept) used together as a tool to facilitate the placement of the stent retriever and apply temporary restriction of blood flow in patients who have suffered a stroke and who undergo mechanical thrombectomy due to acute large vessel occlusion (LVO), presented within 8 hours from symptoms onset (the last time the patient was seen well). Being a mechanical thrombectomy the procedure by which the thrombus that occludes a cerebral vessel is accessed. It is accessed through an endovascular catheter, inserted through the femoral artery, for disruption or removal.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	iNedit, iNdeep, iNtercept	Patients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept

Timeline

• Start date: 2022-07-29
• Primary completion: 2024-08-17
• Completion: 2025-02-25
• First posted: 2023-06-08
• Last updated: 2025-05-16

Locations

18 sites across 3 countries: Belgium, Germany, Spain