NCT07174505

Evaluation of the CONDA Stent Retriever in Acute Ischemic Stroke

A Prospective, Single-Arm, Multi-Center Study to Assess the Safety, Performance, and Preliminary Efficacy of Mechanical Thrombectomy Using the CONDA Stent Retriever in Subjects With Acute Ischemic Stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Anaconda Biomed S.L. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the safety and performance of the CONDA stent retriever in patients with acute ischemic stroke due to large vessel occlusion, treated within 24 hours of symptom onset. The main objectives are: * To determine the rate of device success, defined as the ability of the CONDA retriever to reach the blocked vessel, be deployed and retrieved successfully, and facilitate reperfusion. * To evaluate safety, measured as the rate of symptomatic intracranial hemorrhage within 24 hours of the procedure. The use of CONDA in this study follows the same approach as other CE-marked stent retrievers. Supportive devices (such as long sheaths, guide catheters, balloon catheters, distal access catheters, the ANA funnel catheter, microcatheters, and microwires) may be used according to investigator preference and local practice, in line with their labeling and instructions for use. Participants will: * Be evaluated using standard clinical and imaging assessments to confirm eligibility. * Undergo mechanical thrombectomy with the CONDA device, with or without supportive devices as selected by the treating physician. * Have standard follow-up evaluations to assess treatment safety and effectiveness.

Detailed description

ARTEMIS is a pilot prospective, multi-center, single-arm, open-label, interventional study. Standard of care clinical and imaging stroke assessments will determine subject eligibility. The objective of this study is to assess the performance, safety and preliminary efficacy of mechanical thrombectomy (MT) using the CONDA device in its intended use as a stent retriever to enable the entrapment and removal of clotted blood in the neurovasculature in subjects experiencing acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO) and treated within 24 hours of symptom onset. The ARTEMIS study is designed to demonstrate that the use of CONDA does not adversely impact the safety and effectiveness of a conventional stent retriever MT procedures.

Conditions

• Acute Ischemic Stroke
• Large Vessel Occlusion

Interventions

Type	Name	Description
DEVICE	Mechanical Thrombectomy using the CONDA Stent Retriever	Intravenous sedation, local or general anesthesia, and anticoagulation management will be administered following the institution's standard of care to ensure subject safety and comfort. These procedures should be applied to the target population at the discretion of the investigator and in accordance with clinical guidelines. The use of CONDA is no different than that established for other CE marked stent retrievers. The use of supportive devices including, long sheaths, guide catheters with our without balloons, distal access catheters, ANA funnel catheter, microcatheters and microwires, along with the CONDA device, will be guided by operator preference and/or center established practices. Operators are required to use these devices according to their labeling and instructions for use.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2027-01-01
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

2 sites across 2 countries: Hungary, Spain