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ThrombX Retriever for Acute Ischemic Stroke Trial (TRAC)

Primary Purpose

Ischemic Stroke

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mechanical thrombectomy with ThrombX Retriever

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ThrombX Retriever

Arm Description

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

Outcomes

Primary Outcome Measures

Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever

Defined by a mTICI score >2b

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05270122

First Posted

February 17, 2022

Last Updated

March 10, 2022

Sponsor

ThrombX Medical

1. Study Identification

Unique Protocol Identification Number

NCT05270122

Brief Title

ThrombX Retriever for Acute Ischemic Stroke Trial

Acronym

TRAC

Official Title

ThrombX Retriever for Acute Ischemic Stroke Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2022 (Anticipated)

Primary Completion Date

April 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ThrombX Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single group assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ThrombX Retriever

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Mechanical thrombectomy with ThrombX Retriever

Other Intervention Name(s)

Mechanical Thrombectomy

Intervention Description

Revascularization

Primary Outcome Measure Information:

Title

Successful reperfusion of the occluded target vessel with up to 3 passes of the ThrombX Retriever

Description

Defined by a mTICI score >2b

Time Frame

Up to the end of theprocedure

Title

Safety Endpoint

Description

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Functional independence defined by modified Rankin Scale (mRS)

Description

Time Frame

90 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claire Houston, MS

Phone

65052453467

chouston@thrombxmedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahesh Jayaraman, MD

Organizational Affiliation

Rhode Island Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Raul Nogueira, MD, MD

Organizational Affiliation

University of Pittsburgh Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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ThrombX Retriever for Acute Ischemic Stroke Trial

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