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Clinical Trials in China / NCT04948749
Recruiting Not applicable

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

NCT04948749 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Not applicable
Started
2021-07-02
Last updated
2026-07-15

Condition(s) studied

ICAD - Intracranial Atherosclerotic DiseaseICAS - Intracranial AtherosclerosisDrug-eluting StentStrokeDrug Eluting Stents (DES)Medical Treatment

Investigational drug(s) / intervention(s)

Drug Eluting Stent implantationAggressive medical treatmentRisk factor managementStandard medical treatment

Drug Eluting Stent implantation: The Maurora ® Sirolimus Eluting Stent System for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.

Aggressive medical treatment: Aggressive medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 6 months after enrollment).

Risk factor management: Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)

Standard medical treatment: Standard medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 3 months after enrollment).

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age from 18 to 85 years 2. Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery \[C5-C7\], middle cerebral artery \[M1\], vertebral artery \[V4\], or basilar artery) on CTA (According to WASID method) 3. The diameter of the target vessel between 2.0mm - 4.5mm 4. The stenosis lesion length ≤ 14 mm 5. Baseline modified Rankin Scale (mRS) score ≤ 3 6. Patient understands the purpose and requirements of the study, and has provided informed consent Exclusion Criteria: 1. Ischemic stroke occurred within 7 days before enrolment 2. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery) 3. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic) 4. Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery 5. Stroke caused by perforating artery occlusion 6. CT angiographic evidence of severe calcification at target lesion 7. Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks 8. Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc 9. History of stenting of an intracranial artery 10. Presence of any unequivocal cardiac source of embolism 11. Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation 12. Cannot tolerate dual antiplatelet therapy 13. Contraindications to heparin, rapamycin, contrast and local or general anesthesia 14. Hemoglobin\<100g/L, platelet count \<100×109/L 15. Severe hepatic and renal dysfunction 16. INR\>1.5 or there are uncorrectable factors leading to bleeding 17. Major surgery within the past 30 days or planned within 90 days 18. Renal artery, iliac artery, and coronary artery requiring simultaneous intervention 19. Life expectancy \<1 year 20. Pregnant or lactating women 21. Cannot complete the follow-up due to cognitive, emotional or mental illness 22. Other situations that are not suitable for enrolment according to the judgement of the investigator 23. Enrolment in another study that would conflict with the current study

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Beijing Tiantan Hospital Beijing Beijing Municipality Recruiting
Beijing Daxing District People's Hospital Beijing Beijing Municipality Recruiting
Hejian People's Hospital Cangzhou Hebei Recruiting
North China University of Science and Technology Affiliated Hospital Tangshan Hebei Recruiting
Xingtai City Third Hospital Xingtai Hebei Recruiting
General Hospital of The Yangtze River Shipping Wuhan Hubei Recruiting
Baotou Central Hospital Baotou Inner Mongolia Recruiting
Inner Mongolia Autonomous Region People's Hospital Hohhot Inner Mongolia Recruiting
Tongliao City Hospital Tongliao Inner Mongolia Recruiting
Wuhai People's Hospital Wuhai Inner Mongolia Recruiting
The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu Recruiting
The Second Norman Bethune Hospital of JilinUniversity, Changchun Jilin Recruiting
General Hospital of Benxi Iron and Steel Co Benxi Liaoning Recruiting
Shanxi Cardiovascular Hospital Taiyuan Shanxi Recruiting
Shanxi Provincial People's Hospital Taiyuan Shanxi Recruiting
The First Affiliated Hospital of College of Medicine Hangzhou Zhejiang Recruiting
Lishui People's Hospital Lishui Zhejiang Recruiting
Beilun People's Hospital of Ningbo City Ningbo Zhejiang Recruiting

More Beijing Tiantan Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04948749 on ClinicalTrials.gov ↗ ← All trials in China