Sponsor study identifier
observational
840
1 country
1
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This trial is an prospective, government-funded registration study that will observe the safety and effectiveness of intracranial stenting for preventing stroke during a mean follow-up of 12 months in patients with symptomatic stenosis of a major intracranial artery (MCA, carotid, vertebral, basilar). This trial will be launched by Xuanwu Hospital, Capital University of Medical Science, with 20 collaborators participating. Enrollment will begin in 2013, and it aims to have a sample size of 840 subjects in 2 years. The trial is scheduled to complete in 2015. As we know, SAMMPRIS is flawed with defect in design, heterogeneity in experience and credentials of operators and high rate of complication; Whether the interventional therapy for symtomatic intracranial artery stenosis is effective or not remained resolved. This trial has been modified based on SAMMPRIS in order to acquire the data for China: Technique, experience, and credential of the operators are closely related with perioperative complications in PTAS. The investigators select 50 large-scale medical centers for participation on the basis of geographical distribution. All the participants are ranked as top in China. They have the most experienced surgeons or interventionist in China, and are fully qualified for this trial. This will guarantee the success and safety of technique, maintain the continuity of operator's experience, and make the complication rate as low as possible.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
October 14, 2013
Actual (reported)November 25, 2013
Actual (reported)December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Ischemic stroke, death or cardiovascular events
The participants who suffer from Ischemic stroke, death or cardiovascular events after enrollment or any revascularization procedure of the qualifying lesion in the territory of the symptomatic intracranial artery
30 days
Any stroke, or death
beyond 30 days through 6 months
the number of participants who suffer from restenosis (>50%) related to intracranial stenting
up to 12 months
the changes from baseline in mRS, national institutes of health stroke scale (NIHSS) and Barthel Index
at 7 days, 30 days, 6 months, 12 months, 24 months and 36 months
the number of participants who survives in all patients
beyond 12 months to 36 months
all the participants in this group will be performed with intracranial stenting
all the participants in this group will be performed with intracranial stenting \--------------------------------------------------------------------------------
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
This trial is an prospective, government-funded registration study that will observe the safety and effectiveness of intracranial stenting for preventing stroke during a mean follow-up of 3 years in patients with symptomatic stenosis of a major intracranial artery (MCA, carotid, vertebral, basilar). This trial was launched by Xuanwu Hospital, Capital University of Medical Science, with 20 collaborators participating. Enrollment will begin in 2013, and it aims to have a sample size of 840 subjects in 2 years. The trial is scheduled to complete in 2015.
Department of neurosurgery, Xuanwu hospital
Beijing, 100053, China
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.
Feigin VL. Stroke epidemiology in the developing world. Lancet. 2005 Jun 25-Jul 1;365(9478):2160-1. doi: 10.1016/S0140-6736(05)66755-4. No abstract available.
Feng Ling, MD
Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China
First Submitted
October 14, 2013
First Posted
November 25, 2013
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke
Contact the study team to confirm eligibility.
Zaidat OO, Klucznik R, Alexander MJ, Chaloupka J, Lutsep H, Barnwell S, Mawad M, Lane B, Lynn MJ, Chimowitz M; NIH Multi-center Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology. 2008 Apr 22;70(17):1518-24. doi: 10.1212/01.wnl.0000306308.08229.a3. Epub 2008 Jan 30.
Fiorella D, Levy EI, Turk AS, Albuquerque FC, Niemann DB, Aagaard-Kienitz B, Hanel RA, Woo H, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG. US multicenter experience with the wingspan stent system for the treatment of intracranial atheromatous disease: periprocedural results. Stroke. 2007 Mar;38(3):881-7. doi: 10.1161/01.STR.0000257963.65728.e8. Epub 2007 Feb 8.
Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.
Han Z, Wang T, Li L, Fan J, Wang R, Zheng Y, Yan F, Zhao H, Luo Y, Jiao L. Expression profiles and potential clinical significance of circular RNAs in peripheral neutrophils of patients with intracranial atherosclerotic stenosis. Brain Circ. 2025 Jul 3;11(3):200-211. doi: 10.4103/bc.bc_16_24. eCollection 2025 Jul-Sep.
Zhao F, Wang T, Luo J, Gao H, Zheng Y, Wang R, Fan J, Zhao H, Han Z, Luo Y, Jiao L. Endothelial Glycocalyx in Cerebral Infarction After Endovascular Treatment in Patients With Intracranial Artery Stenosis. CNS Neurosci Ther. 2025 Aug;31(8):e70545. doi: 10.1111/cns.70545.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 25, 2013
Record last verified: 2013-10
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Source: ClinicalTrials.gov.
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