ThrombX Retriever for Acute Ischemic Stroke Trial
About the study
This trial is designed to assess the safety and effectiveness of the ThrombX Retriever.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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 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
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?