Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Device: Cereglide 92
- Registration Number
- NCT06386289
- Lead Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
- Brief Summary
The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- Diagnosis of acute ischemic stroke.
- NIHSS ≥6
- Baseline mRS ≤ 2
- Completed informed consent.
- Known pregnancy.
- Life expectancy less than 90 days prior to stroke onset.
- Known Diagnosis of Dementia
- Treatment with heparin within 48 hours.
- Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic.
- Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
- Baseline CT or MRI showing mass effect
- Concurrent sino-venous thrombosis
- Currently participating in an investigational (drug, device, etc.) clinical trial, excluding trials in observational, natural history, and/or epidemiological studies not involving intervention and that will not confound study endpoints. Sponsor approval is required.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Cereglide 92 Mechanical Thrombectomy
- Primary Outcome Measures
Name Time Method First pass reperfusion Intraprocedural First pass reperfusion (eTICI ≥ 2b50 without additional therapy)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Oregon Health And Science University
🇺🇸Portland, Oregon, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Allegheny General Hospital of Research
🇺🇸Pittsburgh, Pennsylvania, United States
University of Iowa Hospital and Clinics
🇺🇸Iowa City, Iowa, United States
Texas Stroke Institute
🇺🇸Plano, Texas, United States
Mercy Health St Vincent Medical Center
🇺🇸Toledo, Ohio, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
University of Texas Houston
🇺🇸Houston, Texas, United States
JFK Medical Center
🇺🇸Edison, New Jersey, United States