For Healthcare Professionals

ThrombX Retriever for Acute Ischemic Stroke Trial

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About the study

This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Acute anterior circulation ischemic stroke
  2. Pre-stroke Modified Rankin Score ≤ 1
  3. NIHSS ≥ 6 and < 25 immediately prior to enrollment
  4. ASPECT score ≥6 with CT scanning or core infarct volume <50 mL on magnetic MRI or CT based perfusion imaging
  5. Occlusion of IC or the middle cerebral artery M1 or M2 division
  6. Subject can be treated within eight-hours of onset of stroke symptoms

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Pregnant or lactating at time of admission
  2. Known serious sensitivity to radiographic contrast agents
  3. Known sensitivity to nickel, titanium metals, or their alloys
  4. Current participation in another investigation drug or device treatment study
  5. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency prothrombin time lab results to be available prior to enrollment)
  6. Renal failure
  7. Baseline blood glucose of <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L)
  8. Baseline platelet count < 50,000/uL
  9. Severe, sustained hypertension
  10. Presumed septic embolus, suspicion of bacterial endocarditis
  11. Subject has a contraindication to an angiogram
  12. Life expectancy <6 months
  13. Comorbid disease or condition that would confound assessments
  14. Known history of arterial tortuosity, preexisting stent, and/or other arterial disease
  15. Tandem lesions, occlusion requiring angioplasty and/or stent placement or evidence of carotid dissection
  16. Site of occlusion is heavily calcified
  17. Imaging or clinical evidence of bilateral strokes or concomitant posterior circulation stroke
  18. CT or MRI evidence of hemorrhage or evidence of mass effect or intra-cranial tumor
  19. Imaging evidence suggests subject is not appropriate for mechanical thrombectomy
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Ischemic Stroke

Age (in years)

18 - 85

Phase

Not Applicable

Participants needed

200

Est. Completion Date

Jul 31, 2024

Treatment type

Interventional


Sponsor

ThrombX Medical

ClinicalTrials.gov identifier

NCT05270122

Study number

T0268

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