RecruitingPhase 2ACTRN12615000759594

Angioplasty and Stenting versus medical treatment in patients with symptomatic intracranial artery stenosis: a randomized controlled trial and a preference cohort

Effect of angioplasty and stenting versus aggressive medical treatment on mortality and stroke in patients with symptomatic intracranial artery stenosis: a randomized controlled trial and a preference cohort

Sponsor

Fuzhou General Hospital of Nanjing Command, PLA and clinical medical college of Fujian medical university

Enrollment

198 participants

Start Date

Jun 6, 2015

Study Type

Interventional

Conditions

symptomatic intracranial artery stenosis

Summary

Introduction: Recent studies indicated that endovascular stenting is inferior to aggressive medication for reducing cerebrovascular events in patients with symptomatic intracranial stenosis(ICAS). However, a high rate of postprocedure complications and a biased selection of patients raised concerns about the accuracy and stability of the results. Hence, we designed a randomized controlled trial and a preference cohort to examine the effectiveness and safety of an improved protocol of angioplasty and stenting for patients with ICAS. Methods and analysis: This study will be performed in 2 parts, a randomized controlled trial and a preference cohort. In the randomized controlled trial, ICAS patients will be randomized assigned to an angioplasty and stenting group (PTAS) and an aggressive medical treatment group (AMT), after screened by a strict selection criteria. The ICAS patients who are ineligible to the trial will be suggested for a preference to PTAS or AMT, and therefore be included in a preference cohort study. The PTAS will be performed in 3 to 5 days after enrolment, while the AMT will be initiated at the enrolment day. The primary outcome of this study is events of stroke or death within 30 days after enrolment. The secondary outcomes included the incidence of recurrent ischaemic stroke in the territory of the stenosis arteries between 30 days and 2 years postoperatively, the restenosis rate and health-related quality of life during the 2-years follow-up period. Ethics and dissemination: The protocol of this study is approved by the institutional review boards of the participating centers. The results will be disseminated to patients, clinical practitioners and policymakers through publications in journals or conference papers. It is anticipated that the results will improve current PTAS quality and guide clinical decisions for choosing treatments for ICAS patients.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for people who have had strokes or mini-strokes caused by a narrowed artery inside the brain. Researchers are comparing two treatments: a procedure to open the narrowed artery using a small balloon and a stent (a tiny wire tube), versus strong medicines alone. The goal is to find out which approach better prevents future strokes. You may be eligible if: - You are between 18 and 70 years old - You have had a stroke or mini-strokes caused by a narrowed artery in the brain (70–99% blockage) - The narrowed section is 15 mm or shorter and the artery is at least 2 mm wide - Brain scans show reduced blood flow in that area - You are able to give informed consent You may NOT be eligible if: - You cannot receive general anesthesia or angiography - You have had a major brain bleed or large stroke recently - You had a heart attack in the past 30 days - You are pregnant or have childbearing potential without a negative pregnancy test - You have a non-atherosclerotic cause for your artery narrowing (such as sickle cell disease or vasculitis) - You have already had a stent placed in that artery Talk to your doctor about whether this trial might be right for you.

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Interventions

Medical treatment will be given to all the participants. Basic drugs for the treatment are aspirin and clopidogrel. The aspirin and clopidogrel will be given orally at a dose of 100mg and 75mg per day respectively for 3 months. Patients in the PTAS group will receive the same dose of the aspirin and clopidogrel 5 days before operation, and continue for 3 months after the operation. When an emergency stenting operation is needed, a loading dose of 300 mg clopidogrel will be given. Additional medical treatment will be given to achieve a target systolic blood pressure of <140mmHg; hemoglobin A1c of <6.5% (in diabetes patients); low density lipoprotein of <2.58mmol/L. Interventions lowering the cardiovascular risk will also be used, such as lifestyle modification and smoking cessation. Participants who are allocated to PTAS will receive angioplasty and stenting within 5 days after randomization. A standard protocol of the PTAS procedure will be developed. The procedure will be performed by a cardiovascular surgeon. The participants will receive balloon-angioplasty with a balloon catheter, followed by stenting using the Wingspan stent system (manufactured by Stryker Neurovascular).

Locations(1)

Fujian, China

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ACTRN12615000759594