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Ischemic StrokeNCT01994161

Clinical Registration Trial of Intracranial Stenting for Patients With Symptomatic Intracranial Artery Stenosis(CRTICAS)

An observational study of Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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). 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 stenting
Type of treatment
Surgery or procedure
How many people
840 participants
Where
1 siteChina
Study dates
Dec 2012to Dec 2015
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

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

Study population: 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.

Who may be able to join

  • Symptomatic status: as evidenced by TIA or non-severe stroke within the past 12 months attributed to 70% to 99% stenosis of a major intracranial artery (carotid artery, MCA stem [M1], vertebral artery, or basilar artery).
  • Degree of stenosis: 70%-99%; (Stenosis must be confirmed by catheter angiography for enrollment in the trial,WASID method)
  • Age:30-80 years;
  • No fresh infarctions identified on MRI (indicated as high signals on DWI series) upon enrollment
  • No massive cerebral infarction (>1/2 MCA territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan
  • mRS scale score of <=2
Show all 9Show fewer
  • Target vessel reference diameter must be measure d to be 2.00 mm to 4.50 mm; target area of stenosis is <=14 mm in length
  • Patient is willing and able to return for all follow-up visits required by the protocol
  • Patient understands the purpose and requirements of the study, can make him/herself understood, and has signed informed consent.

Who cannot join

  • Untoward reaction to anesthesia.
  • Any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe.
  • Tandem extracranial or intracranial stenosis that is proximal or distal to the target intracranial lesion
  • Previous treatment of target lesion with a stent, angioplasty, or other mechanical device.
  • Any aneurysm proximal to or distal to stenotic intracranial artery. Intracranial tumor (except meningioma) or any intracranial vascular malformation
  • Computed tomographic or angiographic evidence of severe calcification at target lesion
Show all 17Show fewer
  • Stroke of sufficient size (>5cm on CT or MRI) to place patient at risk of hemorrhagic conversion during the procedure.Hemorrhagic transformation of an ischemic stroke within the past 15 days.
  • Previous spontaneous intracerebral (parenchymal) or other intracranial (subarachnoid, subdural, or epidural) hemorrhage within 30 days
  • Untreated chronic subdural hematoma >5 mm in thickness
  • Intracranial arterial stenosis related to arterial dissection, moya-moya disease or any known vasculitic disease;
  • MI within previous 30 days
  • Any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation
  • Intolerance or allergic reaction to any of the study medications, including aspirin, clopidogrel, heparin, nitinol, and local or general anaesthesia History of life-threatening allergy to contrast dye. If not life-threatening and can be effectively pretreated, patient can be enrolled at physicians discretion
  • Recent GI bleed that would interfere with antiplatelet therapy. Active bleeding diathesis or coagulopathy; active peptic ulcer disease, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets count <125,000, hematocrit <30, Hgb <10 g/dl, uncorrected INR >1.5, bleeding time >1 minute beyond upper limit normal, or heparin-associated thrombocytopenia that increases the risk of bleeding, uncontrolled severe hypertension (systolic BP>180 mm hg or diastolic BP>115 mm hg), severe liver impairment (AST or ALT >3 times normal, cirrhosis), creatinine >265.2μmol/l (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
  • Severe dementia or psychiatric problem that prevents the patient from following an outpatient program reliably
  • Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Department of neurosurgery, Xuanwu hospital

    Beijing, 100053

    Liqun Jiao, MD, 86-10-83198899 ext. 8836, jiaoliqun@gmail.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Registration Trial of Intracranial Stenting for Patients With Symptomatic Intracranial Artery Stenosis:A Prospective Multi-center, Registry Trial

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.

Read the detailed description

Title:Clinical Registration Trial of Intracranial Stenting for Patients With Symptomatic Intracranial Artery Stenosis:A Prospective Multi-center, Registry Trial

Design of trial:

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 40 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.

Details:

SAMMPRIS (Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) hasn't received the expected results; But, it does not mean that angioplasty with stent on intracranial treatment come to a full stop. On the contrary, a discrepancy on reported data between multi-centre RCT and most single center studies urges us for thorough investigation in future.

As we know, SAMMPRIS is flawed with defect in design, heterogeneity in experience and credentials of operators and high rate of complication; Some questions about SAMMPRIS have been raised, and remained unresolved.

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 40 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.

SAMMPRIS was stopped ahead of schedule due to the safety concern. More than half of the PTAS patients were lost for follow-up at 1 year, and the remaining were followed up with a mean duration less than 1 year. It leaves the question of long-time follow-up data open. Base on SAMMPRIS, the investigators' trial will conduct a systematic follow-up system. Upon recruitment, all the patients' neurological and imaging examination will be determined at baseline, 1 week, 1 month, 6 months , 12 months after surgery, respectively.

Conditions
Ischemic Stroke
Being tested
intracranial stenting
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 stentingProcedure or surgery

    all the participants in this group will be performed with intracranial stenting

    --------------------------------------------------------------------------------

Study groups in NCT01994161
Study groupRoleWhat they receive
Intracranial stenting groupall the participants in this group will be performed with intracranial stenting
Receives: Procedure: intracranial stenting

What is being measured

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

  1. 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

    Measured: 30 days

Secondary outcomes (4)
  1. Any stroke, or death

    the number of participants who suffer from any stroke(minor or major, ischemic or bleeding) or death

    Measured: beyond 30 days through 6 months

  2. the number of participants who suffer from restenosis (>50%) related to intracranial stenting

    the number of participants who suffer from restenosis (>50%) related to intracranial stenting

    Measured: up to 12 months

  3. the changes from baseline in mRS, national institutes of health stroke scale (NIHSS) and Barthel Index

    the changes from baseline in mRS, national institutes of health stroke scale (NIHSS) and Barthel Index

    Measured: at 7 days, 30 days, 6 months, 12 months, 24 months and 36 months

  4. the number of participants who survives in all patients

    the number of participants who survives in all patients

    Measured: beyond 12 months to 36 months

Timeline

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

  1. First posted25 Nov 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
840 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT01994161
Sponsor's protocol ID
XW125-S003
Status last verified
Oct 2013
First submitted
14 Oct 2013
Last updated
25 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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
  • 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.

    PubMed 15978910
  • 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.

    PubMed 18235078
  • 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.

    PubMed 17290030
  • 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.

    PubMed 15800226
  • 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.

    PubMed 40842453
  • 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.

    PubMed 40808328

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.

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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Liqun Jiao, MD (86-10-83198899 ext. 8836, jiaoliqun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemic stroke, death or cardiovascular events (time frame: 30 days). 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 NCT01994161, which also lists 7 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 25 Nov 2013.

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