Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke (SENTIS)

CoAxia

Status and phase: Completed; Phase 3

Conditions: Cerebrovascular Accident

Treatments: Device: NeuroFlo™ catheter; Other: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT00119717

CD-0125

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of the NeuroFlo™ catheter for use in patients with ischemic stroke. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

Full description

The study is a prospective, controlled, randomized, single-blind, multi-center study of NeuroFlo treatment plus standard medical management versus standard medical management alone. Randomization will be 1:1 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters:

1. National Institute of Health Stroke Scale (NIHSS) at baseline (stratify <10, 11-18)
2. Time from symptom onset (TFSO) to time of baseline NIHSS evaluation (stratify <5 hrs, or ≥5 hrs).

Enrollment: 515 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic stroke
• NIHSS between 5-18
• Time from symptom onset less than 14 hours

Exclusion criteria

• Hemorrhagic stroke
• Certain types of heart disease
• Kidney disease
• Other conditions the doctor will assess

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

515 participants in 2 patient groups

1

Experimental group

Treatment:

Device: NeuroFlo™ catheter

2

Active Comparator group

Treatment:

Other: Control