NCT06733246

Safety and Efficacy Evaluation of the Ceretrieve Device in the Treatment of AIS Patients

Evaluation of the Safey & Performance of the Ceretrieve Device Designed for Thrombus Removal in Intracranial Arteries Using an Aspiration Technique in Patients Suffering an Acute Ischemic Stroke (AIS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Ceretrieve Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this clinical trial is to evaluate of the safety \& efficacy of the Ceretrieve device within 24 hours post thrombectomy procedure. This means to assess that the use with the Ceretrieve neuro-thrombectomy device that is designed to treat acute ischemic stroke patients raises no safety concerns and that it is found to be effective when it is used according to its intended purpose, which is revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (involving the internal carotid artery, middle cerebral artery- M1 and M2 segments, basilar, and vertebral arteries). The study researchers will compare the efficacy and safety results of this study to data derived from the literature of FDA approved neuro-thrombectomy devices. The study hypothesis is that The Ceretrieve device would achieve successful reperfusion performance shall be similar to the safety \& performance derived from the literature. The primary outcomes that will be measures are: Performance: Successful reperfusion, defined as core laboratory-adjudicated modified Thrombolysis in Cerebral Ischemia (mTICI) score 2b-3 within three passes of the Ceretrieve system without any rescue. Safety: Symptomatic intra-cranial hemorrhage within 24 (18-36) hours of the study procedure. Patients who will participate in this study will be followed for a time period of 3 months. After discharge from the medical center, they will be asked to arrive to a one visit at the clinic for safety data collection and evaluation.

Detailed description

This study is designed as a prospective, multi-center, open-label, single-arm study. Patient will be required to undergo screening evaluation to confirm he/she meet the eligibility study criteria and are suitable to be a study participant. The study patient population is comprised of adult subjects 18 years old and above, suffering from acute ischemic stroke, with a new moderate-to-severe neurologic deficits, angiographically confirmed occlusion in the intracranial internal carotid, middle cerebral (M1 or M2 segment), basilar, or vertebral artery, and can undergo endovascular therapy (at least one Ceretrieve deployment in the target artery), within 24 hours of symptoms on set.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	Aspiration 0	Ceretrieve is a neuro-thrombectomy aspiration catheter deigned for clot removal in AIS patients.

Timeline

• Start date: 2024-11-12
• Primary completion: 2027-05-30
• Completion: 2027-08-30
• First posted: 2024-12-13
• Last updated: 2026-03-25

Locations

1 site across 1 country: Germany