Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis

Completed · Phase 3

Conditions studied: Ischemic Stroke

In brief

PRIMARY HYPOTHESIS: Compared with intensive medical therapy alone, intracranial angioplasty and stenting combined with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a mean follow-up of two years in high-risk patients patients with 70% - 99% intracranial stenosis who had a transient ischemic attack (TIA) or stroke within 30 days prior to enrollment) with symptomatic stenosis of a major intracranial artery. SUMMARY: The best treatment for prevention of another stroke or TIA in patients with narrowing of one of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting medications to prevent blood clots from forming in the narrowed vessel. There are a variety of medicines used for this purpose. These medications are usually taken for the rest of a patient's life. However, a treatment that has been used successfully together with anti-clotting medications in patients with narrowing of the blood vessels of the heart is now being studied in the blood vessels of the brain. This treatment is called stenting. Recent research has also indicated a benefit in prevention of recurring stroke by Intensive Medical Therapy, which is defined as treating risk factors for stroke like high blood pressure, elevated LDL (low density lipids - the "bad" form of cholesterol) and diabetes. The purpose of this study is to compare the safety and effectiveness of either Intensive Medical Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks or death. The study will enroll patients over a 5 year period. Each participant will be involved in the study for a minimum of 1 year and a maximum of 3 years. Fifty different medical centers in the United States are part of this study. Both the Clinical Coordinating Center and the Statistical Coordinating Center for the entire study will be located at Emory University.

Key facts

Study ID

NCT00576693

Run by

Medical University of South Carolina

People needed

451

Starts

2008-10-01

Expected to finish

2013-04-01

Last updated by the study team

2018-05-30

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Transient ischemic attack (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 byTranscranial Doppler (TCD), Magnetic Resonance Angiogram (MRA), or computed tomography angiography (CTA) to qualify for angiogram performed as part of the study protocol but must be confirmed by catheter angiography for enrollment in the trial
• Modified Rankin score of ≤ 3
• Target area of stenosis in an intracranial artery that has a normal diameter of 2.00 mm to 4.50 mm
• Target area of stenosis is less than or equal to 14 mm in length
• Age ≥ 30 years and ≤ 80 years.
• Patients 30-49 years are required to meet at least one additional criteria (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.
• i. insulin dependent diabetes for at least 15 years ii. at least 2 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 ii. 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 iv. 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 v. 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
• Negative pregnancy test in a female who has had any menses in the last 18 months
• Patient is willing and able to return for all follow-up visits required by the protocol
• Patient is available by phone
• Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent

You may not qualify if…

• 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)
• 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)
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to expected enrollment date
• 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
• Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to an intracranial stenosis
• Presence of intraluminal thrombus proximal to or at the target lesion
• Any aneurysm proximal to or distal to stenotic intracranial artery
• Intracranial tumor (except meningioma) or any intracranial vascular malformation
• CT or angiographic evidence of severe calcification at target lesion
• Thrombolytic therapy within 24 hours prior to enrollment
• Progressive neurological signs within 24 hours prior to enrollment
• 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
• Any hemorrhagic infarct within 14 days prior to enrollment
• Any hemorrhagic infarct within 15 - 30 days that is associated with mass effect
• Any history of a primary intracerebral (parenchymal) hemorrhage (ICH)
• Any other intracranial hemorrhage (subarachnoid, subdural, epidural) within 30 days
• Any untreated chronic subdural hematoma of greater than 5 mm in thickness
• 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 Cerebrospinal fluid (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
• 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%
• Known allergy or contraindication to aspirin, clopidogrel, heparin, nitinol, local or general anesthesia
• 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
• Active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets < 100,000, hematocrit < 30, International normalized ratio (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 Aspartate Transaminase (AST) or Alanine transaminase (ALT) > 3 x normal, cirrhosis, creatinine > 3.0 (unless on dialysis)
• Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment
• Indication for warfarin or heparin beyond enrollment (NOTE: exceptions allowed for use of systemic heparin during stenting procedure or subcutaneous heparin for deep vein thrombosis (DVT) prophylaxis while hospitalized)
• Severe neurological deficit that renders the patient incapable of living independently

Where it is running

• UAB Medical Center — Birmingham, Alabama, United States
• Barrow Neurological Institute - St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Mayo — Phoenix, Arizona, United States
• Glendale Adventist — Glendale, California, United States
• Cedars Sinai — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• UCSF — San Francisco, California, United States
• Washington Hospital — Washington D.C., District of Columbia, United States
• University of Florida - Shands — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• Florida Hospital — Winter Park, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Central DuPage Hospital — Winfield, Illinois, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Wayne State — Detroit, Michigan, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• Providence St. John — Southfield, Michigan, United States
• University of Mississippi — Jackson, Mississippi, United States
• University of Buffalo — Buffalo, New York, United States
• NYU Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Cornell Medical College — New York, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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