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

Launched by BEIJING TIANTAN HOSPITAL · Jun 24, 2021

Keywords

ClinConnect Summary

The DREAM-PRIDE trial is studying a new way to help prevent strokes from happening again in people who have a specific type of blocked artery in the brain called intracranial atherosclerotic disease. The researchers want to find out if using a special type of stent, called a drug-eluting stent (which releases medication over time), along with strong medical treatment, is better at preventing stroke recurrence within one year compared to just using standard medical treatment alone.

To participate in this study, you need to be between 18 and 85 years old and have had a recent stroke caused by a significant blockage (70% to 99%) in one of the major arteries in your brain. You must also be able to understand the study and give your consent to participate. If you join, you can expect to receive either the new treatment or the standard care, and you will be closely monitored over the next year to see how well the treatment works. It’s important to know that not everyone will qualify for this trial, as there are specific health conditions that could prevent participation.

Gender

ALL

Eligibility criteria

• 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