ThrombX Retriever for Acute Ischemic Stroke Trial (TRAC)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Mechanical thrombectomy with 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire Houston, MS; Phone Number: 65052453467; Email: chouston@thrombxmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ThrombX Retriever; Access to the involved vasculature and preform mechanical thrombectomy using the ThrombX Retriever.	Device: Mechanical thrombectomy with ThrombX Retriever; Revascularization; Other Names: Mechanical Thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever	Defined by a mTICI score >2b	Up to the end of theprocedure
Safety Endpoint	Symptomatic intracerebral hemorrhage (sICH) confirmed on imaging and other Serious Adverse Device Effects (SADE) within 24 hours post procedure. The sICH is defined as the presence of extravascular blood in the cranium associated with an increase in the NIHSS score of ≥ 4 points or death.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional independence defined by modified Rankin Scale (mRS)	modified Ranking Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. The scale runs from 0-6, running from perfect health without symptoms to death.	90 Days

Collaborators and Investigators

• Sponsor: ThrombX Medical
• Investigators: Principal Investigator: Mahesh Jayaraman, MD, Rhode Island Hospital; Principal Investigator: Raul Nogueira, MD, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: T0268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes