Drug-eluting Stent, Drug Eluting Stents (DES), ICAD - Intracranial Atherosclerotic Disease, ICAS - Intracranial Atherosclerosis, Medical Treatment, Stroke
Conditions
Keywords
Stroke, Drug-eluting stent, Medical treatment, ICAD-Intracranial Atherosclerotic Disease, ICAS-Intracranial Atherosclerosis, Drug Eluting Stents (DES)
Brief 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.
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.
Interventions
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).
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual stenosis after the procedure in DES group | 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. |
| In-stent restenosis (ISR) rate in DES group within 12 months | 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. |
| Disabling stroke within 1 year | 12 months after enrollment | defined as modified Rankin Scale \> 3 at 1 year visit |
| Any stroke, death or myocardial infarction within 1 year | 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. |
| Major non-stroke hemorrhage within 1 year | 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. |
| Modified Rankin Scale score at 1 year | 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. |
| Symptomatic intracranial hemorrhage within 1 year | 12 months after enrollment | — |
| Death within 1 year | 12 months after enrollment | Death within 1 year |
Countries
China
Contacts
CONTACTNing Ma, MD
CONTACTBaixue Jia, MD
PRINCIPAL_INVESTIGATORYongjun Wang, MD
Beijing Tiantan Hospital
PRINCIPAL_INVESTIGATORZhongrong Miao, MD
Beijing Tiantan Hospital
Outcome results
None listed