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

Last updated: December 25, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Atherosclerosis

Treatment

Drug Eluting Stent implantation

Risk factor management

Aggressive medical treatment

Clinical Study ID

NCT04948749
HX-A-018(2021)
  • Ages 18-85
  • All Genders

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 Criteria

Inclusion

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 [C4-C7], middlecerebral artery [M1], vertebral artery [V4], or basilar artery) on CTA (According toWASID 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 providedinformed consent

Exclusion

Exclusion Criteria:

  1. Ischemic stroke occurred within 7 days before enrolment

  2. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximalor distal to the target intracranial lesion (NOTE: an exception is allowed ifstenosis or occlusion involves a single vertebral artery proximal to a symptomaticbasilar artery stenosis and the contralateral vertebral artery is supplying thebasilar artery)

  3. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty aboutwhich artery is symptomatic (NOTE: an exception is that if bilateral vertebralarteries with 70%-99% stenosis but unequal in size, the dominant side is consideredas symptomatic)

  4. Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebralartery

  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 haemorrhagein 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 otherintracranial infections, any intracranial stenosis related to cerebrospinal fluidcells, radiation-induced vascular disease, fibromuscular dysplasia, sickle celldisease, neurofibromatosis, central nervous system benign vascular disease,postpartum vascular disease, suspected vasospasm, suspicious embolismrecanalization, 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 arteriovenousmalformation

  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 ofthe investigator

  23. Enrolment in another study that would conflict with the current study

Study Design

Total Participants: 792
Treatment Group(s): 4
Primary Treatment: Drug Eluting Stent implantation
Phase:
Study Start date:
July 02, 2021
Estimated Completion Date:
December 31, 2026

Study Description

This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent combined with aggressive medical treatment versus standard medical treatment to treat symptomatic intracranial atherosclerotic disease. Primary efficacy endpoints (any of the following): 1) any stroke or death within 30 days after enrollment, 2) any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up, 3) ischemic stroke in the territory of the qualifying artery beyond 30 days to 1 year.

Connect with a study center

  • Beijing Daxing District People's Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Beijing Tiantan Hospital

    Beijing, Beijing 100070
    China

    Active - Recruiting

  • Hejian People's Hospital

    Cangzhou, Hebei
    China

    Active - Recruiting

  • North China University of Science and Technology Affiliated Hospital

    Tangshan, Hebei
    China

    Active - Recruiting

  • Xingtai City Third Hospital

    Xingtai, Hebei
    China

    Active - Recruiting

  • General Hospital of The Yangtze River Shipping

    Wuhan, Hubei
    China

    Active - Recruiting

  • Baotou Central Hospital

    Baotou, Inner Mongolia
    China

    Active - Recruiting

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia
    China

    Active - Recruiting

  • Tongliao City Hospital

    Tongliao, Inner Mongolia
    China

    Active - Recruiting

  • Wuhai People's Hospital

    Wuhai, Inner Mongolia
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • The Second Norman Bethune Hospital of JilinUniversity,

    Changchun, Jilin
    China

    Active - Recruiting

  • General Hospital of Benxi Iron and Steel Co

    Benxi, Liaoning
    China

    Active - Recruiting

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi
    China

    Active - Recruiting

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi
    China

    Active - Recruiting

  • The First Affiliated Hospital of College of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Lishui People's Hospital

    Lishui, Zhejiang
    China

    Active - Recruiting

  • Beilun People's Hospital of Ningbo City

    Ningbo, Zhejiang
    China

    Active - Recruiting

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