Acute Ischemic Stroke
Conditions
Brief summary
The TRUST study is a non-interventional, prospective, multicenter, international, single arm and non-inferiority study. It is designed to evaluate the efficacy and safety of mechanical thrombectomy of the CATCHVIEW device compared to SOLITAIRE 2/FR based on an objective performance criterion (OPC) defined with available and published clinical evidence gathered through the Solitaire clinical trials in the arterial revascularization of patients with acute ischemic stroke.
Interventions
DEVICECATCHVIEW
Revascularization device
Sponsors
Balt Extrusion
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
* Age ≥ 18 and ≤ 80 years old * Clinical signs consistent with acute ischemic stroke * Pre-stroke modified Rankin Score ≤ 1 * Patient able to be treated within 8 hours of onset of stroke symptoms and within 2 hours between qualifying imaging from CTA or MRA to groin puncture * Initial NIHSS ≥ 6 and \< 30 at the time of inclusion * Arterial occlusion in the intracranial internal carotid, M1/M2 segment of the MCA, carotid terminus or tandem proximal ICA/MCA-M1 confirmed by CT or MR angiography that is accessible to the device * Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., patient presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without partial or complete recanalization * Primary use of the CATCHVIEW stent retriever for the procedure (decision of use is done independently and prior to the participation of the patient in the study) * Life expectancy of at least 90 days * Ability of the patient or legally authorized representative to provide a signed and dated informed consent form before the procedure. Where applicable, in case of medical emergency not allowing the patient to provide consent and unavailability of the legally authorized representative, a physician who does not take part in the study will sign the informed consent before the procedure. In any case, the patient or the legally authorized representative consent shall be requested as soon as possible after the procedure up until the discharge visit.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Score (mRS) | 90 days | Proportion of patients achieving functional independence (mRS ≤ 2) |
Outcome results
None listed