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

NCT01994161 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 840

Last updated 2013-11-25

No results posted yet for this study

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). 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.

Conditions

Interventions

PROCEDURE

intracranial stenting

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

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Feng Ling, MD · Xuanwu Hospital, Capital University of Medical Sciences, Beijing, China

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01994161 on ClinicalTrials.gov