ThrombX Retriever for Acute Ischemic Stroke Trial

NCT ID: NCT05270122

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2024-07-31

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ThrombX Retriever

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

Group Type: EXPERIMENTAL

Mechanical thrombectomy with ThrombX Retriever

Intervention Type: DEVICE

Revascularization

Interventions

Mechanical thrombectomy with ThrombX Retriever

Revascularization

Intervention Type: DEVICE

Other Intervention Names

Mechanical Thrombectomy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ThrombX Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahesh Jayaraman, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Raul Nogueira, MD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Central Contacts

Claire Houston, MS

Role: CONTACT

chouston@thrombxmedical.com

65052453467

Other Identifiers

T0268

Identifier Type: -

Identifier Source: org_study_id