Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial (DREAM-PRIDE)

December 25, 2024 updated by: Beijing Tiantan Hospital

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

792

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Daxing District People'S Hospital
        • Contact:
        • Contact:
          • Jinglin Yuan
    • Hebei
      • Cangzhou, Hebei, China
        • Recruiting
        • Hejian People's Hospital
        • Contact:
        • Contact:
          • Dong Sun
      • Tangshan, Hebei, China
        • Recruiting
        • North China University of Science and Technology Affiliated Hospital
        • Contact:
        • Contact:
          • Chengjing Xue
      • Xingtai, Hebei, China
        • Recruiting
        • Xingtai City Third Hospital
        • Contact:
        • Contact:
          • Yingyi Li
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • General Hospital of The Yangtze River Shipping
        • Contact:
        • Contact:
          • Wanming Wang
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • Baotou Central Hospital
        • Contact:
          • Changchun Jiang
        • Contact:
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Inner Mongolia Autonomous Region People's Hospital
        • Contact:
        • Contact:
          • Rile Wu
      • Tongliao, Inner Mongolia, China
        • Recruiting
        • Tongliao City Hospital
        • Contact:
          • Peng Xu
        • Contact:
      • Wuhai, Inner Mongolia, China
        • Recruiting
        • Wuhai People's Hospital
        • Contact:
        • Contact:
          • Hu Shen
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:
          • Guibing Ding
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The Second Norman Bethune Hospital of JilinUniversity,
        • Contact:
        • Contact:
          • Long Yan
    • Liaoning
      • Benxi, Liaoning, China
        • Recruiting
        • General Hospital of Benxi Iron and Steel Co
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Provincial People's Hospital
        • Contact:
          • Yaxuan Sun
          • Phone Number: 86+13834578394
          • Email: rvlm@163.com
        • Contact:
          • Yaxuan Sun
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Cardiovascular Hospital
        • Contact:
          • Dong Kuai
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of College of Medicine
        • Contact:
        • Contact:
          • Ziqi Xu
      • Lishui, Zhejiang, China
        • Recruiting
        • Lishui People's Hospital
        • Contact:
        • Contact:
          • Lin Xiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • Beilun People's Hospital of Ningbo City
        • Contact:
        • Contact:
          • Xing Fang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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], 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug-eluting stent implantation with aggressive medical treatment group
DES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
Device: 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.
Other Names:
  • Maurora ® Sirolimus Eluting Stent implantation
Drug: 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).
Other Names:
  • Dual antiplatelet therapy for 6 months
Behavioral: Risk factor management
Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
Other Names:
  • Risk factor and life style management
Active Comparator: Standard medical treatment group
Standard medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 3 months after enrolment), management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
Behavioral: Risk factor management
Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
Other Names:
  • Risk factor and life style management
Drug: 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).
Other Names:
  • Dual antiplatelet therapy for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe or moderate bleeding (GUSTO score)
Time Frame: 12 months after enrollment

Bleeding events were defined according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification for severe or life-threatening, moderate, or mild bleeding:

Severe or life-threatening- Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention

Moderate- Bleeding that requires blood transfusion but does not result in hemodynamic compromise

Mild- Bleeding that does not meet criteria for either severe/life-threatening or moderate bleeding
12 months after enrollment
Any stroke or death within 30 days of enrollment or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.
Time Frame: 12 months after enrollment
Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year. Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. Symptomatic brain hemorrhage is defined as parenchymal, subarachnoid, or intraventricular hemorrhage detected by CT or MRI that is associated with new neurological signs or symptoms (headache, change in level of consciousness, focal neurological symptoms) lasting ≥ 24 hours or a seizure.
12 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-stent restenosis (ISR) rate in DES group within 12 months
Time Frame: 12 months after enrollment
The ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss.
12 months after enrollment
Disabling stroke within 1 year
Time Frame: 12 months after enrollment
defined as modified Rankin Scale > 3 at 1 year visit
12 months after enrollment
Any stroke, death or myocardial infarction within 1 year
Time Frame: 12 months after enrollment
Any stroke included ischemic stroke and symptomatic brain hemorrhage. Symptomatic brain hemorrhage refers to parenchymal, subarachnoid, or intraventricular hemorrhage that was associated with a seizure or with symptoms or signs lasting 24 hours or longer.
12 months after enrollment
Major non-stroke hemorrhage within 1 year
Time Frame: 12 months after enrollment
A major non-stroke-related hemorrhage was defined as any subdural or epidural hemorrhage or a systemic hemorrhage requiring hospitalization, blood transfusion, or surgery.
12 months after enrollment
Modified Rankin Scale score at 1 year
Time Frame: 12 months after enrollment
The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.
12 months after enrollment
Death within 1 year
Time Frame: 12 months after enrollment
Death within 1 year
12 months after enrollment
Residual stenosis after the procedure in DES group
Time Frame: At the end of the procedure
Degree of residual stenosis was measured and calculated according to the methods of the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial.
At the end of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Yongjun Wang, MD, Beijing Tiantan Hospital
  • Principal Investigator: Zhongrong Miao, MD, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

July 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 25, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX-A-018(2021)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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