Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT04948749

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial

Led by Beijing Tiantan Hospital · Updated on 2024-12-27

792

Participants Needed

18

Research Sites

282 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 18 to 85 years
  • Ischemic stroke within 30 days before enrollment 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) confirmed by CTA
  • Diameter of the target vessel between 2.0 mm and 4.5 mm
  • Length of the stenosis lesion 64 14 mm
  • Baseline modified Rankin Scale (mRS) score 64 3
  • Patient understands the study purpose and has provided informed consent
Not Eligible

You will not qualify if you...

  • Ischemic stroke occurred within 7 days before enrollment
  • Tandem extracranial or intracranial stenosis (70%-99%) or occlusion proximal or distal to the target lesion, except for specific vertebral artery cases
  • Bilateral intracranial vertebral artery stenosis (70%-99%) with uncertainty about symptomatic side, except if dominant side can be identified
  • Unilateral vertebral artery stenosis (70%-99%) with normal contralateral vertebral artery
  • Stroke caused by perforating artery occlusion
  • Severe calcification at target lesion on CT angiography
  • History of brain parenchymal or subarachnoid, subdural or extradural hemorrhage in past 6 weeks
  • Intracranial artery stenosis caused by non-atherosclerotic lesions such as arterial dissection, Moyamoya disease, vasculitis, viral vascular diseases, neurosyphilis, intracranial infections, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, CNS benign vascular disease, postpartum vascular disease, suspected vasospasm, or embolism recanalization
  • History of stenting of an intracranial artery
  • Presence of any definite cardiac source of embolism
  • Combined intracranial tumor, aneurysm, or arteriovenous malformation
  • Inability to tolerate dual antiplatelet therapy
  • Contraindications to heparin, rapamycin, contrast agents, or anesthesia
  • Hemoglobin less than 100 g/L or platelet count less than 100�d7109/L
  • Severe liver or kidney dysfunction
  • INR greater than 1.5 or uncorrectable bleeding risk factors
  • Major surgery within past 30 days or planned within 90 days
  • Need for simultaneous intervention of renal, iliac, or coronary arteries
  • Life expectancy less than 1 year
  • Pregnant or breastfeeding women
  • Inability to complete follow-up due to cognitive, emotional, or mental illness
  • Other conditions judged unsuitable by the investigator
  • Enrollment in conflicting studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

2

Beijing Daxing District People's Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

3

Hejian People's Hospital

Cangzhou, Hebei, China

Actively Recruiting

4

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, China

Actively Recruiting

5

Xingtai City Third Hospital

Xingtai, Hebei, China

Actively Recruiting

6

General Hospital of The Yangtze River Shipping

Wuhan, Hubei, China

Actively Recruiting

7

Baotou Central Hospital

Baotou, Inner Mongolia, China

Actively Recruiting

8

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Actively Recruiting

9

Tongliao City Hospital

Tongliao, Inner Mongolia, China

Actively Recruiting

10

Wuhai People's Hospital

Wuhai, Inner Mongolia, China

Actively Recruiting

11

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Actively Recruiting

12

The Second Norman Bethune Hospital of JilinUniversity,

Changchun, Jilin, China

Actively Recruiting

13

General Hospital of Benxi Iron and Steel Co

Benxi, Liaoning, China

Actively Recruiting

14

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Actively Recruiting

15

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Actively Recruiting

16

The First Affiliated Hospital of College of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

17

Lishui People's Hospital

Lishui, Zhejiang, China

Actively Recruiting

18

Beilun People's Hospital of Ningbo City

Ningbo, Zhejiang, China

Actively Recruiting

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Research Team

N

Ning Ma, MD

CONTACT

B

Baixue Jia, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial | DecenTrialz