Clinical trial NCT05270122: ThrombX Retriever for Acute Ischemic Stroke Trial
Official title: ThrombX Retriever for Acute Ischemic Stroke Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: ThrombX Medical
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

Brief summary: This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.

Detailed description: This trial is a clinical evaluation is to assess the safety and effectiveness of the ThrombX Retriever in the revascularization of the site of primary occlusion in patients presenting with acute ischemic stroke secondary to intracranial, large vessel, occlusive disease.

Eligibility criteria: Inclusion Criteria:

* Acute anterior circulation ischemic stroke
* Pre-stroke Modified Rankin Score ≤ 1
* NIHSS ≥ 6 and \< 25 immediately prior to enrollment
* ASPECT score ≥6 with CT scanning or core infarct volume \<50 mL on magnetic MRI or CT based perfusion imaging
* Occlusion of IC or the middle cerebral artery M1 or M2 division
* Subject can be treated within eight-hours of onset of stroke symptoms

Exclusion Criteria:

* Pregnant or lactating at time of admission
* Known serious sensitivity to radiographic contrast agents
* Known sensitivity to nickel, titanium metals, or their alloys
* Current participation in another investigation drug or device treatment study
* Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency prothrombin time lab results to be available prior to enrollment)
* Renal failure
* Baseline blood glucose of \<50mg/dL (2.78 mmol/L) or \>400mg/dL (22.20 mmol/L)
* Baseline platelet count \< 50,000/uL
* Severe, sustained hypertension
* Presumed septic embolus, suspicion of bacterial endocarditis
* Subject has a contraindication to an angiogram
* Life expectancy \<6 months
* Comorbid disease or condition that would confound assessments
* Known history of arterial tortuosity, preexisting stent, and/or other arterial disease
* Tandem lesions, occlusion requiring angioplasty and/or stent placement or evidence of carotid dissection
* Site of occlusion is heavily calcified
* Imaging or clinical evidence of bilateral strokes or concomitant posterior circulation stroke
* CT or MRI evidence of hemorrhage or evidence of mass effect or intra-cranial tumor
* Imaging evidence suggests subject is not appropriate for mechanical thrombectomy

Primary outcomes:
measure: Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever
timeFrame: Up to the end of theprocedure
measure: Safety Endpoint
timeFrame: 24 hours
Secondary outcomes:
measure: Functional independence defined by modified Rankin Scale (mRS)
timeFrame: 90 Days
Other outcomes:
Locations:
Study officials:
affiliation: Rhode Island Hospital
name: Mahesh Jayaraman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Raul Nogueira, MD, MD
role: PRINCIPAL_INVESTIGATOR
References: