Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID04948749

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)

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

792

Participants Needed

18

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether using a drug-eluting stent combined with aggressive medical treatment can better prevent stroke recurrence within one year compared to standard medical treatment alone for people with symptomatic intracranial atherosclerotic disease. This prospective, multi-center trial randomly assigns participants to either treatment and focuses on stroke or death events within 30 days and ischemic stroke in the affected artery territory from 31 days up to one year. Participants receive either the Maurora® Sirolimus Eluting Stent implantation along with aggressive medical treatment, including aspirin daily for the entire follow-up, plus clopidogrel or ticagrelor for six months, along with management of risk factors such as hypertension and diabetes; or they receive standard medical treatment with aspirin for the entire follow-up, plus clopidogrel or ticagrelor for three months, and similar risk factor management. The study compares these two approaches over a 12-month period. During the study, participants will have assessments to monitor stroke or death occurrence, bleeding events, and other health outcomes such as in-stent restenosis and disability scores up to one year after enrollment. Follow-up includes imaging to evaluate residual vessel narrowing and monitoring for adverse events. Participants are tracked closely for safety and efficacy outcomes throughout the trial duration, which ends in December 2026.

CONDITIONS

Brief 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 caused by 70% to 99% narrowing of a major intracranial artery (internal carotid C4-C7, middle cerebral M1, vertebral V4, or basilar artery) confirmed by CTA
  • Target artery diameter between 2.0 mm and 4.5 mm
  • Stenosis lesion length 14 mm or less
  • Baseline modified Rankin Scale score of 3 or less
  • Understands the study purpose and provides informed consent
Not Eligible

You will not qualify if you...

  • Ischemic stroke within 7 days before enrollment
  • Tandem extracranial or intracranial artery narrowing (70%-99%) or occlusion near the target lesion except specific vertebral artery cases
  • Bilateral vertebral artery stenosis with uncertainty of symptomatic side except if one side is dominant
  • Unilateral vertebral artery stenosis with normal opposite artery
  • Stroke caused by perforating artery occlusion
  • Severe calcification at target lesion seen on CT angiography
  • Brain hemorrhage within past 6 weeks
  • Intracranial artery narrowing due to non-atherosclerotic causes such as dissection, Moyamoya disease, vasculitis, infections, or other specified conditions
  • Previous intracranial artery stenting
  • Any definite cardiac source of embolism
  • Intracranial tumor, aneurysm, or arteriovenous malformation
  • Cannot tolerate dual antiplatelet therapy
  • Contraindications to heparin, rapamycin, contrast dye, or anesthesia
  • Low hemoglobin (<100 g/L) or platelet count (<100 x10^9/L)
  • Severe liver or kidney dysfunction
  • High INR (>1.5) or uncorrectable bleeding risk
  • Major surgery within past 30 days or planned within 90 days
  • Need for simultaneous intervention in other arteries
  • Life expectancy less than 1 year
  • Pregnant or breastfeeding women
  • Cognitive, emotional, or mental illness preventing follow-up
  • Other conditions judged unsuitable by investigator
  • Participation in conflicting clinical trials

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Up to 1 year

Participants in the experimental group receive the drug-eluting stent implantation procedure combined with aggressive medical treatment and risk factor management. Participants in the comparator group receive standard medical treatment and risk factor management.

Initial procedure visit plus ongoing treatment visits

Follow-up

Duration - 12 months after enrollment

Participants are monitored for stroke, death, bleeding events, and other health outcomes for up to 12 months after enrollment.

Regular follow-up visits during the 12-month period

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

B

Baixue Jia, MD

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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Published Research Related To This Trial

Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.

Maigeng Zhou, Haidong Wang, Xinying Zeng...

https://pubmed.ncbi.nlm.nih.gov/31248666

Wingspan stenting for intracranial atherosclerotic stenosis: clinical outcomes and risk factors for in-stent restenosis.

Yong Sam Shin, Byung Moon Kim, Sang Hyun Suh...

https://pubmed.ncbi.nlm.nih.gov/23277374