Multicenter Studies

The NSICU in collaboration with the departments of neurosurgery, neurology and hematology participates in a variety of multi-center studies. Their inclusion and exclusion criteria are listed below.

Aruba Trial

A Randomized Study of Unruptured Brain Arteriovenous malformations
http://www.arubastudy.org/

Patients with unruptured arteriovenous malformations (AVM) are eligible for this trial. Patients are randomized to standard medical management of symptoms related to the AVM versus interventional therapy (embolization, surgical resection or radiation). Consenting subjects are followed for 5 years after randomization. This trial is NIH funded. Mount Sinai site PI: Jennifer Frontera, MD; contact Deborah Carson for enrollment at (212) 241-6758.

Inclusion Criteria:

  1. Unruptured brain AVM diagnosed by MRI/MRA and/or angiogram
  2. Age: 18 years or older
  3. Signed informed consent, release of medical information and Health Insurance Portability and Accountability Act (HIPAA) forms

Exclusion Criteria:

  1. Brain AVM with evidence of recent or prior hemorrhage
  2. Prior brain AVM therapy
  3. Brain AVM deemed untreatable
  4. Baseline mRS: 2 or greater
  5. Concomitant disease reducing life expectancy to < 10 years
  6. Thrombocytopenia
  7. Uncorrectable coagulopathy
  8. Pregnant or lactating
  9. Known allergy to iodine contrast agent
  10. Multiple-foci brain AVM
  11. Patient has any previous diagnosis of other intracranial or spinal vascular malformations

MISTIE - Minimally Invasive Surgery plus T-PA for Intracerebral Hemorrhage Evacuation

http://mistietrial.com/default.aspx

This is a safety, feasibility and dose finding study of patients with intracerebral hemorrhage (ICH). Consented patients undergo intraoperative stereotactic CT guided endoscopic surgery and catheter placement into the ICH. A one time clot-aspiration is followed by 72 hours of rt-PA instillation into the hematoma site. This is an NIH funded project. Mount Sinai site PI: Joshua Bederson, MD. Contact Sandra Augustine for enrollment, pager 917-248-1299.

Inclusion Criteria:

  1. Age 18-80
  2. GCS < 14 or a NIHSS (including the use of distal hand measures) > 6
  3. Spontaneous supratentorial ICH > 20 cc
  4. Symptoms less than 12 hours prior to diagnostic CT scan (an unknown time of symptom onset is exclusionary)
  5. Intention to initiate surgery within 48 hours after diagnostic CT
  6. First dose can be given within 54 hours of diagnostic CT
  7. Six-hour clot size equal to the most previous clot size + 5 cc (as determined by additional CT scan at least 6 hours after the initial stability scan (A*B*C)/2 method)
  8. SBP < 200 mmHg sustained for 6 hours recorded closest to the time of randomization
  9. Historical Rankin score of 0 or 1
  10. Negative pregnancy test.

Exclusion Criteria:

  1. Infratentorial hemorrhage including brainstem (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy)
  2. Patients with platelet count < 100,000, INR > 1.7, or an elevated PT or APTT (reversal of coumadin is permitted but the patient must not require coumadin during the acute hospitalization). Irreversible coagulopathy either due to medical condition or prior to randomization (patient must have a sustained INR < 1.7 using short- and long-acting procoagulants [Novoseven, FFP, and/or vitamin K])
  3. Clotting disorders
  4. Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenteroligic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease
  5. Patients with a mechanical valve
  6. Patients with unstable mass or evolving intracranial compartment syndrome
  7. Ruptured aneurysm, AVM, vascular anomaly
  8. Greater than 80 years of age (higher incidence of amyloid)
  9. Under 18 years of age (high incidence of occult vascular malformation)
  10. Pregnant (positive pregnancy test) or lactating females (likelihood of altered coagulation function associated with the high estrogen/progesterone state)
  11. Irreversibly impaired brainstem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS less than or equal to four;
  12. Historical Rankin score greater than or equal to two
  13. Intraventricular hemorrhage requiring external ventricular drainage
  14. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts
  15. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention
  16. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis
  17. In the investigator’s opinion, the patient is unstable and would benefit from a specific intervention rather than supportive care plus or minus endoscopic or MIS+rtPA (18) Prior enrollment in the study
  18. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  19. Participation in another simultaneous trial of ICH treatment.

Clear IVH Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage

http://clearivh.com/default.aspx

This is a Phase III randomized clinical trial using rt-PA to treat subjects with intracerebral hemorrhage (ICH), intraventricular hemorrhage (IVH) and hydrocephalus. This is an NIH funded trial. Mount Sinai site PI: Stanley Tuhrim, MD. Contact Sandra Augustine for enrollment, pager 917-248-1299.

Inclusion Criteria:

  1. Age 18-75
  2. IVC (intraventricular catheter or external ventricular drain) placed as standard of care using less than or equal to two complete passes
  3. Spontaneous ICH < 30cc
  4. Presentation with diagnosis of IVH within 12 hours of onset and able to receive first dose within 48 hours of diagnostic CT
  5. Clot size after six hours must be equal to the presentation clot size + 5 cc (as determined by the (AxBxC)/2 method)
  6. On stability CT scan either the 3rd or 4th ventricles are occluded with blood
  7. Systolic blood pressure < 200 mm Hg sustained for 6 hours
  8. Historical Rankin of 0 or 1.

Exclusion Criteria:

  1. Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI)
  2. Clotting disorders
  3. Platelet count < 100,000, INR > 1.7 (reversal prior to enrollment is permitted), PT > 15s, or elevated APTT
  4. Pregnancy
  5. Infratentorial hemorrhage (parenchymal/posterior fossa hematoma; all cerebellar hematomas are excluded)
  6. SAH (if angiogram rules out underlying pathology as source of bleeding, patient is eligible for enrollment)
  7. ICH enlargement during the 6-hour stabilization period
  8. Internal or superficial bleeding
  9. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis
  10. Prior enrollment in the study
  11. Any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  12. Participation in another simultaneous medical investigation or trial.

SAMMPRIS - Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke

http://clinicaltrials.gov/ct2/show/NCT00576693?term=SAMMPRIS&rank=1

This is a randomized, open label parallel assignment study of intracranial stenting (wingspan stent) plus intensive medical therapy versus intensive medical therapy alone for preventing second stroke in high-risk patients with symptomatic stenosis of a major intracranial artery. This study is NIH funded. Mount Sinai site PI: Aman Patel, MD. For enrollment contact Deborah Carson at (212) 241-6758.

Inclusion criteria:

  1. TIA or non-severe stroke within 30 days of enrollment attributed to 70-99% stenosis of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery) - may be diagnosed by TCD, MRA, or CTA to qualify for angiogram performed as part of the study protocol but must be confirmed by catheter angiography for enrollment in the trial
  2. Modified Rankin score of 3 or less
  3. Target area of stenosis in an intracranial artery that has a normal diameter of 2.00 mm to 4.50 mm
  4. Target area of stenosis is less than or equal to 14 mm in length
  5. Age: between 30-80 years.
  6. Patients 30-49 years are required to meet at least one additional criterion (i-vi) provided in the table below to qualify for the study. This additional requirement is to increase the likelihood that the symptomatic intracranial stenosis in patients 30-49 years is atherosclerotic.
  7. insulin dependent diabetes for at least 15 years
  8. at least two of the following atherosclerotic risk factors: hypertension (BP > 140/90 or on antihypertensive therapy); dyslipidemia (LDL > 130 mg /dl or HDL < 40 mg/dl or fasting triglycerides > 150 mg/dl or on lipid lowering therapy); smoking; non-insulin dependent diabetes or insulin dependent diabetes of less than 15 years duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was < 55 years of age for men or < 65 for women at the time of the event
  9. history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease
  10. any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic
  11. aortic arch atheroma documented by non-invasive vascular imaging or catheter angiography vi. any aortic aneurysm documented by non-invasive vascular imaging or catheter angiography that is considered atherosclerotic
  12. Negative pregnancy test in a female who has had any menses in the last 18 months
  13. Patient is willing and able to return for all follow-up visits required by the protocol
  14. Patient is available by phone
  15. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent

Exclusion criteria:

  1. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if the occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)
  2. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (e.g. if patient has pontine, midbrain, or temporal - occipital symptoms)
  3. Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
  4. Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform staged angioplasty followed by stenting of target lesion
  5. Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis
  6. Presence of intraluminal thrombus proximal to or at the target lesion
  7. Any aneurysm proximal to or distal to stenotic intracranial artery
  8. Intracranial tumor (except meningioma) or any intracranial vascular malformation
  9. CT or angiographic evidence of severe calcification at target lesion
  10. Thrombolytic therapy within 24 hours prior to enrollment
  11. Progressive neurological signs within 24 hours prior to enrollment
  12. Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cms) to be at risk of hemorrhagic conversion during or after stenting
  13. Any hemorrhagic infarct within 14 days prior to enrollment
  14. Any hemorrhagic infarct within 15 - 30 days that is associated with mass effect
  15. Any history of a primary intracerebral (parenchymal) hemorrhage (ICH)
  16. Any other intracranial hemorrhage (subarachnoid, subdural, epidural) within 30 days
  17. Any untreated chronic subdural hematoma of greater than 5 mm in thickness
  18. Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with CSF pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus
  19. Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%
  20. Known allergy or contraindication to aspirin, clopidogrel, heparin, nitinol, local or general anesthesia
  21. History of life-threatening allergy to contrast dye. If not life-threatening and can be effectively pretreated, patient can be enrolled at physician's discretion
  22. Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, INR > 1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115 mm Hg), severe liver impairment (AST or ALT > 3 x normal, cirrhosis), creatinine > 3.0 (unless on dialysis)
  23. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment
  24. Indication for heparin beyond enrollment (medical arm) or stenting procedure (stenting arm) or indication for warfarin beyond enrollment
  25. Severe neurological deficit that renders the patient incapable of living independently
  26. Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably
  27. Co-morbid conditions that may limit survival to less than 3 years
  28. Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
  29. Enrollment in another study that would conflict with the current study

Choice: Carotid Stenting for High Surgical-Risk Patients

http://clinicaltrials.gov/ct2/show/NCT00406055?cond=%22Carotid+Artery+Diseases%22&rank=42

This is a non-randomized, open label, historical control, single group assignment, safety/efficacy study of the Abbott vascular carotid stent system and embolic protection system for carotid stenting. This study provides ongoing post-market surveillance of the RX ACCULINK, RX ACCUNET, XACT and EMBOSHIELD devices. This study is funded by Abbott. Mount Sinai site PI: Aman Patel, MD. For enrollment contact Deborah Carson at (212) 241-6758.

Inclusion criteria:

  1. Patient or patient's legally authorized representative provided informed consent.
  2. Patient is considered at high risk for carotid endarterectomy (CEA).
  3. Patient requires percutaneous carotid angioplasty and stenting for carotid artery disease.
  4. Patient’s physician intends to use an RX Acculink with the RX Accunet in the carotid artery or an Xact with the Emboshield in the carotid artery as per the FDA approved Indications for Use as outlined.

Exclusion criteria:

There are no exclusion criteria for this study.


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Neuroscience ICU
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Fax: 212-426-7629

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