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New treatment option for ICAD - Intracranial Atherosclerotic Disease
Official title Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial
ClinicalTrials.gov ID: NCT04948749
What this study is testing
What is Aggressive medical treatment?
Aggressive medical treatment is an investigational medicine, being studied as a potential treatment for icad - intracranial atherosclerotic disease.
Also referred to as Dual antiplatelet therapy for 6 months.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age from 18 to 85 years
- Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery...
- The diameter of the target vessel between 2.0mm - 4.5mm
- The stenosis lesion length ≤ 14 mm
- Baseline modified Rankin Scale (mRS) score ≤ 3
You likely can't join if
- Ischemic stroke occurred within 7 days before enrolment
- Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception...
- Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if...
- Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
- Stroke caused by perforating artery occlusion
- CT angiographic evidence of severe calcification at target lesion
See the full eligibility criteria
- Age from 18 to 85 years
- 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...
- The diameter of the target vessel between 2.0mm - 4.5mm
- The stenosis lesion length ≤ 14 mm
- Baseline modified Rankin Scale (mRS) score ≤ 3
- Patient understands the purpose and requirements of the study, and has provided informed consent
- Ischemic stroke occurred within 7 days before enrolment
- 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...
- 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...
- Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
- Stroke caused by perforating artery occlusion
- CT angiographic evidence of severe calcification at target lesion
- Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks
- 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...
- History of stenting of an intracranial artery
- Presence of any unequivocal cardiac source of embolism
- Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
- Cannot tolerate dual antiplatelet therapy
- Contraindications to heparin, rapamycin, contrast and local or general anesthesia
- Hemoglobin\<100g/L, platelet count \<100×109/L
- Severe hepatic and renal dysfunction
- INR\>1.5 or there are uncorrectable factors leading to bleeding
- Major surgery within the past 30 days or planned within 90 days
- Renal artery, iliac artery, and coronary artery requiring simultaneous intervention
- Life expectancy \<1 year
- Pregnant or lactating women
- Cannot complete the follow-up due to cognitive, emotional or mental illness
- Other situations that are not suitable for enrolment according to the judgement of the investigator
- Enrolment in another study that would conflict with the current study
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Cangzhou, Hebei, China
- Tangshan, Hebei, China
- Xingtai, Hebei, China
- Wuhan, Hubei, China
- Baotou, Inner Mongolia, China
- Hohhot, Inner Mongolia, China
- Tongliao, Inner Mongolia, China
- Wuhai, Inner Mongolia, China
- Nanjing, Jiangsu, China
- Changchun, Jilin, China
- Benxi, Liaoning, China
- Taiyuan, Shanxi, China
- Hangzhou, Zhejiang, China
- Lishui, Zhejiang, China
- Ningbo, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Cangzhou, Hebei, China; Tangshan, Hebei, China; Xingtai, Hebei, China; Wuhan, Hubei, China; Baotou, Inner Mongolia, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.