RecruitingNot ApplicableNCT04948749

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

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)


Sponsor

Beijing Tiantan Hospital

Enrollment

792 participants

Start Date

Jul 2, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

  • 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

Exclusion Criteria23

  • Ischemic stroke occurred within 7 days before enrolment
  • 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)
  • 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)
  • Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
  • Stroke caused by perforating artery occlusion
  • CT angiographic evidence of severe calcification at target lesion
  • Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks
  • 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
  • History of stenting of an intracranial artery
  • Presence of any unequivocal cardiac source of embolism
  • Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
  • Cannot tolerate dual antiplatelet therapy
  • Contraindications to heparin, rapamycin, contrast and local or general anesthesia
  • Hemoglobin\<100g/L, platelet count \<100×109/L
  • Severe hepatic and renal dysfunction
  • INR\>1.5 or there are uncorrectable factors leading to bleeding
  • Major surgery within the past 30 days or planned within 90 days
  • Renal artery, iliac artery, and coronary artery requiring simultaneous intervention
  • Life expectancy \<1 year
  • Pregnant or lactating women
  • Cannot complete the follow-up due to cognitive, emotional or mental illness
  • Other situations that are not suitable for enrolment according to the judgement of the investigator
  • Enrolment in another study that would conflict with the current study

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Interventions

DEVICEDrug 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.

DRUGAggressive 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).

BEHAVIORALRisk factor management

Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)

DRUGStandard 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).


Locations(18)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Beijing Daxing District People's Hospital

Beijing, Beijing Municipality, China

Hejian People's Hospital

Cangzhou, Hebei, China

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, China

Xingtai City Third Hospital

Xingtai, Hebei, China

General Hospital of The Yangtze River Shipping

Wuhan, Hubei, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Tongliao City Hospital

Tongliao, Inner Mongolia, China

Wuhai People's Hospital

Wuhai, Inner Mongolia, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

The Second Norman Bethune Hospital of JilinUniversity,

Changchun, Jilin, China

General Hospital of Benxi Iron and Steel Co

Benxi, Liaoning, China

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, China

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of College of Medicine

Hangzhou, Zhejiang, China

Lishui People's Hospital

Lishui, Zhejiang, China

Beilun People's Hospital of Ningbo City

Ningbo, Zhejiang, China

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NCT04948749


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