Recruiting
Not applicable
Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial
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
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)
- 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. — 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.
- Severe or moderate bleeding (GUSTO score) — 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
Trial sites (18)
| Facility | City | Region | Status |
| 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 |
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