ThrombX Retriever for Acute Ischemic Stroke Trial

NCT05270122 | Unknown DMC FDA Device

• 1 other identifier: T0268
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Functional independence defined by modified Rankin Scale (mRS)

  90 Days

Study Arms (1)

ThrombX Retriever

EXPERIMENTAL

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

Device: Mechanical thrombectomy with ThrombX Retriever

Interventions

Mechanical thrombectomy with ThrombX Retriever DEVICE

Revascularization

Also known as: Mechanical Thrombectomy

ThrombX Retriever

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ThrombX Medical: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mahesh Jayaraman, MD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

• Raul Nogueira, MD, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Houston, MS

CONTACT

65052453467; chouston@thrombxmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group assignment

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 8, 2022
• Study Start: May 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share