Medical Device for Stroke Clots
Protocol: STUDY00005540
Full Title
Delphi early feasability study
An early feasibility study to evaluate the safety and efficacy of Delphi Revascularization device for clot retrieval. This is for hospital patients with Anterior circulation ischemic stroke. Up to 8hrs of symptom onset or last known well time.
Compensation: No
At least 18 years of age at time of consent;
The patient or patient’s LAR has signed and dated an ICD using the Institutional Review Board (IRB) and Medtronic Approved ICD and agrees to comply with protocol requirements. Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization has been provided and signed by the patient or patient’s LAR
Has baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 8;
Able to be treated within 8 hours of stroke symptom onset or Last Known Normal (LKN);
Confirmed LVO in the anterior circulation (i.e., intracranial ICA, M1 or proximal dominant M2) as confirmed by CTA or MRA;
Has a Pre-stroke Modified Rankin Score (mRS) ≤ 1;
Has an Alberta Stroke Program Early CT Score (ASPECTS) 6 – 10;
Use of Solitaire device as primary approach to thrombectomy, with or without conjunct aspiration
Age Group: Adults
Principal Investigator: ADNAN SIDDIQUI
+1 716-888-4811
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