ThrombX Retriever for Acute Ischemic Stroke Trial (TRAC)

ThrombX Medical

Status: Not yet enrolling

Conditions: Ischemic Stroke

Treatments: Device: Mechanical thrombectomy with ThrombX Retriever

Study type: Interventional

Funder types: Industry

Identifiers

NCT05270122

T0268

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

ThrombX Retriever

Experimental group

Description:

Access to the involved vasculature and preform mechanical thrombectomy using the ThrombX Retriever.

Treatment:

Device: Mechanical thrombectomy with ThrombX Retriever