• Welcome toCalifornia Institute of

    Neuroscience

  • Overcome complexneurological disorders

    Improved quality of life

  • Asif Taqi, MD

    COO & Co founder of CIN

  • Martin Mortazavi, MD

    Neurosurgeon CEO & Founder

Clinical Trials

 

1) ATLAS Trial

SAfety and Effectiveness of the Treatment of Wide Neck, Saccular IntracraniaL Aneurysms with the Neuroform Atlas™ Stent System

Sponsor: Stryker Neurovascular
Site Principal Investigator: Dr. M. Asif Taqi, MD, FAHA
Site Sub-Principal Investigator: Dr. Ajeet Sodhi, MD

Primary Objective

The primary objective of the trial is to demonstrate safety and effectiveness of the Neuroform AtlasTM Stent in stent-assisted coil embolization of brain aneurysms with wide neck.

Description of study

Atlas trial is a prospective non-randomized multi-center single arm study of wide neck saccular brain aneurysm in which participating patients will be treated with stent-assisted coiling of aneurysm using the Neuroform AtlasTM stent system. The AtlasTM stent is an investigational device that has been approved by the U.S. Food & Drug Administration (FDA) via a Humanitarian Device Exemption (HDE) supplement. It is currently indicated for use with embolic coils for the treatment of wide neck intracranial saccular aneurysm that are not amenable to surgical treatment.

Once the patient agrees to participate in the trial, pre-procedure screening which will include tests and physical examination, will be done to determine eligibility of the participant. If the patient is determined to be eligible, he or she will be enrolled in the trial and will be prescribed two anti-platelet medications: Aspirin and Clopidogrel. The procedure will involve the delivery of Neuroform AtlasTM stent across the part of brain vessel from which aneurysm is coming off. Subsequently the cavity of aneurysm will be packed with small metallic coils. Following the procedure, patient will receive standard medical and nursing care in the hospital and will be monitored for any discomfort or adverse event. In this trial, patient will be required to do follow up office visits at 2,6 and 12 months after the procedure. In these visit, patient will be assessed by the study team for neurological examinations and for monitoring of any potential adverse event.

Endpoints of Study

The primary endpoints of this trial include assessment of treated aneurysm occlusion 12-month angiogram and development of any major stroke or neurological death within 12 months of the procedure. The secondary endpoints include any serious adverse event, sub-arachnoid hemorrhage (SAH), aneurysm rupture, incidence of re-treatment, incidence of recanalization, incidence of parent artery stenosis, incidence of stent migration based on follow up angiogram.

2) Trevo® Retriever Registry

Sponsor: Stryker Neurovascular
Site Principal Investigator: Dr. M. Asif Taqi, MD, FAHA
Site Sub-Principal Investigator: Dr. Ajeet Sodhi, MD

Primary Objective

The primary objective of the study is to assess the real-world performance of Trevo® Retriever used in the thrombectomy procedure to remove a clot from a brain blood vessel.

Description of Study

Trevo® Retriever Registry is a post-marketing phase IV multicenter nationwide registry of patients who were treated with mechanical thorombectomy to treat Acute Ischemic Stroke (AIS) and Trevo® Retriever was used to remove the clot and restore blood flow in the brain. The Trevo® Retriever is a self-expanding stent like device which is deployed across the clot in a blood vessel to physically retrieve the clot out of the body.

Trevo® Retriever Registry is a prospective registry in which data will be collected from patients’ medical records from the point when patient developed symptoms of stroke till patient is discharged from the treating hospital. Data which will be collected may include medical history, demographics, physicians’ notes, test results, brain imaging exams, reports of procedure and cost of patients’ treatment and hospital stay. After discharge from the hospital, patient will be followed for 3 months for a routine check of patient’s general health and for monitoring of any potential adverse event.

Endpoints of Study

The primary endpoint of study is the assessment of re-vascularization at the end of procedure. The secondary endpoints include assessment of patient’s ability to do daily activities using modified Rankin Scale (mRS), all-cause mortality, assessment of any adverse event related to the procedure or device.

3) ISST Registry

Ideal Sedation for Stroke Thrombectomy (ISST) Registry

Sponsor: Investigator initiated study
Principal Investigator: Dr. M. Asif Taqi, MD, FAHA
Sub-Principal Investigator: Dr. Ajeet Sodhi, MD

Primary Objective

The primary objective of this study is to evaluate the feasibility of two sedation protocols and determine whether intubation of the patient before mechanical thrombectomy can result in delay to recanalization of occluded brain vessel.

Description of Study

ISST is a prospective open-label consecutive enrollment registry, approved by Western Institutional Review Board (WIRB). Being a pilot study the registry will only be evaluating the feasibility and time duration to recanalize a blood vessel of brain using either of the two techniques of sedation.

All acute ischemic stroke patients who underwent intra-arterial treatment, will be screened for enrolled in the study. Once the patient or legally authorized representative sign the consent form, patient will be enrolled and data will be collected from patient’s medical records from the point when patient developed symptoms of stroke till patient is discharged from the treating hospital. Data which will be collected may include medical history, demographics, physicians’ notes, test results, brain imaging exams, reports of procedure and cost of patients’ treatment and hospital stay. After discharge from the hospital, follow up assessment will be done at 1 month and 3 month for a routine check of patient’s general health and for monitoring of any potential adverse event.

Endpoints of Study

The primary endpoint of study is to evaluate if general anesthesia results in delay in time to recanalize occluded blood vessel. The secondary endpoints include assessment of recanalization grade using thrombolysis in cerebral infarction (TICI) score, number of passes performed, Subarachnoid hemorrhage or Intracranial hemorrhage post-procedure and assessment of patient’s ability to do daily activities using modified Rankin Scale (mRS).

4) POINT Trial

Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial

Sponsor: The National Institute of Neurological Disorders and Stroke (NINDS)
Site Principal Investigator: Dr. M. Asif Taqi

Primary Objective

The primary objective of this trial is to determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel with aspirin 50-325 mg/day is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when compared with aspirin 50-325 mg/day alone.

Description of Study

POINT trial is a prospective, randomized, double blind, multicenter trial in patient with high-risk transient ischemic attach (TIA) or minor ischemic stroke will be randomized within 12 hours of time last known free of new ischemic symptoms.

Patients who have had a TIA or minor stroke have a higher risk of developing a major stroke. Recognizing and treating TIAs can reduce your risk of a major stroke. Often, medication to prevent blood clots from forming is used to prevent a stroke in patients with blockage of one of the arteries in the brain. Low-dose aspirin has been shown to be effective in preventing strokes and heart attacks in patients who have had a TIA. Clopidogrel is another medication that is used to prevent strokes and heart attacks in patients at risk for these problems.

If a patient had a TIA and can be randomized within 12 hours of onset of new ischemic symptoms, the trial will be offered by the study team. If the patient agrees to participate and sign the consent form, he or she will be randomly assigned to one of the two groups described below:

Group 1: Patient will be given an initial dose of 600 mg (8 tablets each of 75 mg) of clopidogrel on the first day and then 75 mg (1 tablet) of clopidogrel each day for the next 89 days. Patient will also be given 50-325 mg of aspirin each day for 90 days; the dose of aspirin will be determined by the treating physician.

OR

Group 2: Patient will be given an initial dose of 8 tablets of placebo, a tablet containing an inactive substance, on the first day and then 1 tablet of placebo each day for the next 89 days. Patient will also be given 50-325 mg of aspirin each day for 90 days; the dose of aspirin will be determined by the treating physician.

This is a double-blind study, which means that neither study team nor the patient will know which of the study drug groups, the patient will be randomly assigned to. However, this information will be available in the case of an emergency. The patient will be followed for three months and follow up assessments will be done at 7 days and 90 days’ milestone.

Endpoints of Study

The primary endpoint of this trial is a composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or ischemic vascular death at 90 days.

California Institute of Neuroscience

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