Clinical trial NCT06386289: Safety, Performance of CEREGLIDE 92 Intermediate Catheter in Treatment of Acute Ischemic Stroke
Official title: Safety, Performance and Lesion Evaluation of Neurothrombectomy Using CEREGLIDE 92 Intermediate Catheter: A Prospective Multi-Center Single-Arm IDE Trial (SPLENDID)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acute ischemic stroke.
* NIHSS ≥6
* Baseline mRS ≤ 2
* Completed informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: First pass reperfusion
timeFrame: Intraprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Edison
country: United States
facility: JFK Medical Center
state: New Jersey
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St Vincent Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health And Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital of Research
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of Texas Houston
state: Texas
city: Plano
country: United States
facility: Texas Stroke Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Vanderbilt University Medical Center
name: Michael Froehler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: JFK University Medical Center
name: Brian Jankowitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia University
name: Ansaar Rai, MD
role: PRINCIPAL_INVESTIGATOR
References: