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

Not Applicable

Recruiting

• Conditions: ICAD - Intracranial Atherosclerotic Disease; ICAS - Intracranial Atherosclerosis; Drug-eluting Stent; Stroke; Drug Eluting Stents (DES); Medical Treatment
• Interventions: Device: Drug Eluting Stent implantation; Behavioral: Risk factor management; Drug: Standard medical treatment; Drug: Aggressive medical treatment

• Registration Number: NCT04948749
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-24
• Study Start: 2021-07-02
• Study First Posted: 2021-07-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 792

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard medical treatment group	Standard medical treatment	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)
Drug-eluting stent implantation with aggressive medical treatment group	Drug Eluting Stent implantation	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)
Drug-eluting stent implantation with aggressive medical treatment group	Aggressive medical treatment	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)
Standard medical treatment group	Risk factor management	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)
Drug-eluting stent implantation with aggressive medical treatment group	Risk factor management	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Death within 1 year	12 months after enrollment	Death within 1 year

Trial Locations

Locations (18)

Beijing Daxing District People's Hospital; 🇨🇳 Beijing, Beijing, China

Hejian People's Hospital; 🇨🇳 Cangzhou, Hebei, China

North China University of Science and Technology Affiliated Hospital; 🇨🇳 Tangshan, Hebei, China

Xingtai City Third Hospital; 🇨🇳 Xingtai, Hebei, China

General Hospital of The Yangtze River Shipping; 🇨🇳 Wuhan, Hubei, China

Baotou Central Hospital; 🇨🇳 Baotou, Inner Mongolia, China

Inner Mongolia Autonomous Region People's Hospital; 🇨🇳 Hohhot, Inner Mongolia, China

Tongliao City Hospital; 🇨🇳 Tongliao, Inner Mongolia, China

Wuhai People's Hospital; 🇨🇳 Wuhai, Inner Mongolia, China

The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

The Second Norman Bethune Hospital of JilinUniversity,; 🇨🇳 Changchun, Jilin, China

General Hospital of Benxi Iron and Steel Co; 🇨🇳 Benxi, Liaoning, China

Shanxi Cardiovascular Hospital; 🇨🇳 Taiyuan, Shanxi, China

Shanxi Provincial People's Hospital; 🇨🇳 Taiyuan, Shanxi, China

The First Affiliated Hospital of College of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Lishui People's Hospital; 🇨🇳 Lishui, Zhejiang, China

Beilun People's Hospital of Ningbo City; 🇨🇳 Ningbo, Zhejiang, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China