Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial: a Prospective, Randomized, Open-labelled, Blinded End-point Trial (DREAM-PRIDE)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug, Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Age from 18 to 85 years
• Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery \[C4-C7\], middle cerebral artery \[M1\], vertebral artery \[V4\], or basilar artery) on CTA (According to WASID method)
• The diameter of the target vessel between 2.0mm - 4.5mm
• The stenosis lesion length ≤ 14 mm
• Baseline modified Rankin Scale (mRS) score ≤ 3
• Patient understands the purpose and requirements of the study, and has provided informed consent
Locations
Other Locations
China
Baotou Central Hospital
RECRUITING
Baotou
Beijing Daxing District People's Hospital
RECRUITING
Beijing
Beijing Tiantan Hospital
RECRUITING
Beijing
General Hospital of Benxi Iron and Steel Co
RECRUITING
Benxi
Hejian People's Hospital
RECRUITING
Cangzhou
The Second Norman Bethune Hospital of JilinUniversity,
RECRUITING
Changchun
The First Affiliated Hospital of College of Medicine
RECRUITING
Hangzhou
Inner Mongolia Autonomous Region People's Hospital
RECRUITING
Hohhot
Lishui People's Hospital
RECRUITING
Lishui
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Beilun People's Hospital of Ningbo City
RECRUITING
Ningbo
Shanxi Cardiovascular Hospital
RECRUITING
Taiyuan
Shanxi Provincial People's Hospital
RECRUITING
Taiyuan
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
Tongliao City Hospital
RECRUITING
Tongliao
Wuhai People's Hospital
RECRUITING
Wuhai
General Hospital of The Yangtze River Shipping
RECRUITING
Wuhan
Xingtai City Third Hospital
RECRUITING
Xingtai
Contact Information
Primary
Ning Ma, MD
maning_03@hotmail.com
13581889908
Backup
Baixue Jia, MD
beckyberry@163.com
15010125093
Time Frame
Start Date:2021-07-02
Estimated Completion Date:2026-12
Participants
Target number of participants:792
Treatments
Experimental: Drug-eluting stent implantation with aggressive medical treatment group
DES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
Active_comparator: Standard medical treatment group
Standard medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 3 months after enrolment), management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)