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Ischemic StrokePhase 3SAMMPRISNCT00576693

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

A Phase 3 study testing intracranial angioplasty and stenting and intensive medical management in people with Ischemic Stroke, run by Medical University of South Carolina at 50 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Ischemic Stroke
What is being tested?
intracranial angioplasty and stenting and intensive medical management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
50 sitesUnited States
Study dates
Oct 2008to Apr 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.
  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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
  • Dementia or psychiatric problem that prevents the patient from following an outpatient program reliably
  • Co-morbid conditions that may limit survival to less than 3 years
  • Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study
  • Enrollment in another study that would conflict with the current study

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

United States50 sites

  • Emory University

    Atlanta, Georgia, 30388

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • UAB Medical Center

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Buffalo

    Buffalo, New York, 14209

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Riverside Methodist

    Columbus, Ohio, 43214

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwestern

    Dallas, Texas, 75390

  • Wayne State

    Detroit, Michigan, 48201

  • Henry Ford Medical Center

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • University of Florida - Shands

    Gainesville, Florida, 32611

  • Glendale Adventist

    Glendale, California, 91203

  • Moses Cone Medical Center

    Greensboro, North Carolina, 27401

  • Baylor St. Luke's

    Houston, Texas, 77030

  • Methodist Hospital

    Houston, Texas, 77030

  • University of Mississippi

    Jackson, Mississippi, 39216

  • Cedars Sinai

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90095

  • University of Miami

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • West Virginia University

    Morgantown, West Virginia, 26506

  • NYU Medical Center

    New York, New York, 10016

  • Columbia University Medical Center

    New York, New York, 10032

  • Cornell Medical College

    New York, New York, 10065

  • Sentera

    Norfolk, Virginia, 23507

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19170

  • Barrow Neurological Institute - St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Mayo

    Phoenix, Arizona, 85054

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • UCSF

    San Francisco, California, 94143

  • Providence St. John

    Southfield, Michigan, 48075

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Stony Brook University Medical Center

    Stony Brook, New York, 11790

  • MultiCare

    Tacoma, Washington, 98405

  • Scott & White - Texas A&M

    Temple, Texas, 76508

  • Washington Hospital

    Washington D.C., District of Columbia, 20010

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Florida Hospital

    Winter Park, Florida, 32789

Other trials in United States

About this study

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.

Read more

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.

Read the detailed description

This will be an investigator initiated and designed Phase III multicenter trial in which patients with TIA or non-disabling stroke within 30 days prior to enrollment that is caused by 70% - 99% stenosis of a major intracranial artery (MCA, carotid, vertebral, or basilar) will be randomized (1:1) at approximately 50 sites to:

intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)

OR

intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).

Risk factor management will be performed by the study neurologist at each site who will be assisted by an innovative, evidence-based, educational, lifestyle modification program (INTERxVENT) that will be administered at regularly scheduled times to all patients throughout the study.

All patients enrolled in the trial will be followed until the first of the following: 90 days after a primary endpoint, death, or the close-out visit in the trial, which will occur within a window from 60 days before March 31, 2012 to 30 days after March 31, 2013. Patients who do not die or have a primary endpoint during follow-up will be followed for 2-4.5 years.

Conditions
Ischemic Stroke
Being tested
intracranial angioplasty and stenting, intensive medical management
Keywords
ischemic stroke, intracranial stenting, vascular risk factor management
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intracranial angioplasty and stentingDevice

    Also called Wingspan stent, Gateway balloon

    intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).

  • intensive medical managementOther

    intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)

Study groups in NCT00576693
Study groupRoleWhat they receive
intensive medical management plus stentingExperimentalintracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).
Receives: Device: intracranial angioplasty and stenting
intensive medical management aloneExperimentalIntensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)
Receives: Other: intensive medical management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment.

    Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment OR any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up, OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up.

    Measured: Mean length of follow-up was 2.4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2007 (estimated)
  2. Study startOct 2008
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00576693
Sponsor's protocol ID
R01NS058728-01A1
Other IDs
NINDS, CRC, 1U01NS058728-01A1
Acronym
SAMMPRIS
Status last verified
Apr 2018
First submitted
7 Dec 2007
Last updated
30 May 2018
Data monitoring committee
Yes

Publications

  • Derdeyn CP, Fiorella D, Lynn MJ, Barnwell SL, Zaidat OO, Meyers PM, Gobin YP, Dion J, Lane BF, Turan TN, Janis LS, Chimowitz MI; SAMMPRIS Trial Investigators. Impact of operator and site experience on outcomes after angioplasty and stenting in the SAMMPRIS trial. J Neurointerv Surg. 2013 Nov;5(6):528-33. doi: 10.1136/neurintsurg-2012-010504. Epub 2012 Sep 12.

    PubMed 22977278

  • Turan TN, Lynn MJ, Nizam A, Lane B, Egan BM, Le NA, Lopes-Virella MF, Hermayer KL, Benavente O, White CL, Brown WV, Caskey MF, Steiner MR, Vilardo N, Stufflebean A, Derdeyn CP, Fiorella D, Janis S, Chimowitz MI; SAMMPRIS Investigators. Rationale, design, and implementation of aggressive risk factor management in the Stenting and Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial. Circ Cardiovasc Qual Outcomes. 2012 Sep 1;5(5):e51-60. doi: 10.1161/CIRCOUTCOMES.112.966911. No abstract available.

    PubMed 22991350

  • Fiorella D, Derdeyn CP, Lynn MJ, Barnwell SL, Hoh BL, Levy EI, Harrigan MR, Klucznik RP, McDougall CG, Pride GL Jr, Zaidat OO, Lutsep HL, Waters MF, Hourihane JM, Alexandrov AV, Chiu D, Clark JM, Johnson MD, Torbey MT, Rumboldt Z, Cloft HJ, Turan TN, Lane BF, Janis LS, Chimowitz MI; SAMMPRIS Trial Investigators. Detailed analysis of periprocedural strokes in patients undergoing intracranial stenting in Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS). Stroke. 2012 Oct;43(10):2682-8. doi: 10.1161/STROKEAHA.112.661173. Epub 2012 Sep 13.

    PubMed 22984008

  • Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.

    PubMed 21899409

  • Derdeyn CP, Chimowitz MI, Lynn MJ, Fiorella D, Turan TN, Janis LS, Montgomery J, Nizam A, Lane BF, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Lynch JR, Zaidat OO, Rumboldt Z, Cloft HJ; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial Investigators. Aggressive medical treatment with or without stenting in high-risk patients with intracranial artery stenosis (SAMMPRIS): the final results of a randomised trial. Lancet. 2014 Jan 25;383(9914):333-41. doi: 10.1016/S0140-6736(13)62038-3. Epub 2013 Oct 26.

    PubMed 24168957

  • Hegde S, Tariq MB, Kaneko N, Hinman JD, Liebeskind DS. Territorial Stroke in SAMMPRIS: Critical Analyses of Stroke Prevention in Intracranial Atherosclerosis. Stroke Vasc Interv Neurol. 2026 Jun 23;6(4):e002100. doi: 10.1161/SVIN.125.002100. eCollection 2026 Jul.

    PubMed 42404828

  • Siegler JE, Badillo Goicoechea E, Yaghi S, Morsi RZ, Arevalo A, Smith MM, Kothari S, Desai H, Sehgal N, Rana R, Kellogg CA, Jhaveri A, de Havenon A, Dunne T, Cameron K, Chaturvedi S, Ghannam M, Prabhakaran S, Coleman E, Brorson JR, Mehendale R, Kass-Hout T. Estimated Theoretical Benefit of Aggressive LDL Lowering in Patients With Symptomatic Intracranial Atherosclerosis. Neurology. 2025 Jul 8;105(1):e213768. doi: 10.1212/WNL.0000000000213768. Epub 2025 May 30.

    PubMed 40446174

  • Wang T, Luo J, Li T, Almallouhi E, Gao P, Gong H, Zhang X, Wang J, Lu T, Yang Y, Yang R, Xing Z, Wang H, Derdeyn CP, Jiao L. Stenting versus medical treatment alone for symptomatic intracranial artery stenosis: a preplanned pooled individual patient data analysis. J Neurointerv Surg. 2025 Sep 12;17(10):1032-1039. doi: 10.1136/jnis-2024-022189.

    PubMed 39147573

  • Yaghi S, Khatri P, de Havenon A, Yeatts S, Chang AD, Cutting S, Mac Grory B, Burton T, Jayaraman MV, McTaggart RA, Fiorella D, Derdeyn C, Zaidat OO, Dehkharghani S, Amin-Hanjani S, Furie K, Prahbakaran S, Liebeskind D. Peri-procedural stroke or death in stenting of symptomatic severe intracranial stenosis. J Neurointerv Surg. 2020 Apr;12(4):374-379. doi: 10.1136/neurintsurg-2019-015225. Epub 2019 Sep 4.

    PubMed 31484697

  • Wabnitz AM, Derdeyn CP, Fiorella DJ, Lynn MJ, Cotsonis GA, Liebeskind DS, Waters MF, Lutsep H, Lopez-Cancio E, Turan TN, Montgomery J, Janis LS, Lane B, Chimowitz MI; SAMMPRIS Investigators. Hemodynamic Markers in the Anterior Circulation as Predictors of Recurrent Stroke in Patients With Intracranial Stenosis. Stroke. 2019 Jan;50(1):143-147. doi: 10.1161/STROKEAHA.118.020840. Epub 2018 Dec 11.

    PubMed 30580705

  • Derdeyn CP, Fiorella D, Lynn MJ, Turan TN, Cotsonis GA, Lane BF, Montgomery J, Janis LS, Chimowitz MI; SAMMPRIS Investigators. Nonprocedural Symptomatic Infarction and In-Stent Restenosis After Intracranial Angioplasty and Stenting in the SAMMPRIS Trial (Stenting and Aggressive Medical Management for the Prevention of Recurrent Stroke in Intracranial Stenosis). Stroke. 2017 Jun;48(6):1501-1506. doi: 10.1161/STROKEAHA.116.014537. Epub 2017 Apr 28.

    PubMed 28455321

  • Turan TN, Nizam A, Lynn MJ, Egan BM, Le NA, Lopes-Virella MF, Hermayer KL, Harrell J, Derdeyn CP, Fiorella D, Janis LS, Lane B, Montgomery J, Chimowitz MI. Relationship between risk factor control and vascular events in the SAMMPRIS trial. Neurology. 2017 Jan 24;88(4):379-385. doi: 10.1212/WNL.0000000000003534. Epub 2016 Dec 21.

    PubMed 28003500

  • Waters MF, Hoh BL, Lynn MJ, Kwon HM, Turan TN, Derdeyn CP, Fiorella D, Khanna A, Sheehan TO, Lane BF, Janis S, Montgomery J, Chimowitz MI; Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial Investigators. Factors Associated With Recurrent Ischemic Stroke in the Medical Group of the SAMMPRIS Trial. JAMA Neurol. 2016 Mar;73(3):308-15. doi: 10.1001/jamaneurol.2015.4315.

    PubMed 26747792

  • Kwon HM, Lynn MJ, Turan TN, Derdeyn CP, Fiorella D, Lane BF, Montgomery J, Janis LS, Rumboldt Z, Chimowitz MI; SAMMPRIS Investigators. Frequency, Risk Factors, and Outcome of Coexistent Small Vessel Disease and Intracranial Arterial Stenosis: Results From the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial. JAMA Neurol. 2016 Jan;73(1):36-42. doi: 10.1001/jamaneurol.2015.3145.

    PubMed 26618534

  • Lutsep HL, Lynn MJ, Cotsonis GA, Derdeyn CP, Turan TN, Fiorella D, Janis LS, Lane BF, Montgomery J, Chimowitz MI; SAMMPRIS Investigators. Does the Stenting Versus Aggressive Medical Therapy Trial Support Stenting for Subgroups With Intracranial Stenosis? Stroke. 2015 Nov;46(11):3282-4. doi: 10.1161/STROKEAHA.115.009846. Epub 2015 Sep 17.

    PubMed 26382173

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing intracranial angioplasty and stenting and intensive medical management in people with Ischemic Stroke, run by Medical University of South Carolina at 50 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment. (time frame: Mean length of follow-up was 2.4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00576693, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.

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