Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.
Maigeng Zhou, Haidong Wang, Xinying Zeng...
https://pubmed.ncbi.nlm.nih.gov/31248666Actively Recruiting
Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID04948749
Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease: A Prospective, Randomized, Open-Label Trial
Led by Beijing Tiantan Hospital · Updated on 2024-12-27
792
Participants Needed
18
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of drug-eluting stents combined with aggressive medical treatment compared to standard medical treatment alone in preventing stroke recurrence within one year for patients with symptomatic intracranial atherosclerotic disease. This prospective, multi-center, randomized trial focuses on patients who have experienced ischemic stroke related to severe narrowing of major intracranial arteries. The study aims to assess stroke and death rates within 30 days of enrollment or revascularization procedures, as well as ischemic strokes occurring up to one year after enrollment. Participants are randomly assigned to receive either a drug-eluting sirolimus stent implanted using a balloon-expandable system along with aggressive medical treatment or standard medical treatment alone. Aggressive treatment includes dual antiplatelet therapy with aspirin plus clopidogrel or ticagrelor for six months, while standard treatment involves similar medications for three months. Both groups receive risk factor management addressing hypertension, diabetes, lipid metabolism, smoking, and exercise. The stent system features a rapid exchange catheter with a semi-compliant balloon for intracranial artery treatment. During the study, participants undergo regular monitoring to track any strokes, death, or bleeding complications over 12 months. Key assessments include clinical evaluations and safety monitoring for bleeding severity using the GUSTO score. The trial measures the occurrence of stroke or death within the first 30 days after enrollment or revascularization and ischemic strokes in the treated artery territory from 31 days to one year. The total follow-up period lasts 12 months to evaluate the long-term outcomes of these treatments.
CONDITIONS
Official Title
Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age from 18 to 85 years
- Ischemic stroke within 30 days before enrollment 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) confirmed by CTA
- Diameter of the target vessel between 2.0 mm and 4.5 mm
- Length of the stenosis lesion 64 14 mm
- Baseline modified Rankin Scale (mRS) score 64 3
- Patient understands the study purpose and has provided informed consent
You will not qualify if you...
- Ischemic stroke occurred within 7 days before enrollment
- Tandem extracranial or intracranial stenosis (70%-99%) or occlusion proximal or distal to the target lesion, except for specific vertebral artery cases
- Bilateral intracranial vertebral artery stenosis (70%-99%) with uncertainty about symptomatic side, except if dominant side can be identified
- Unilateral vertebral artery stenosis (70%-99%) with normal contralateral vertebral artery
- Stroke caused by perforating artery occlusion
- Severe calcification at target lesion on CT angiography
- History of brain parenchymal or subarachnoid, subdural or extradural hemorrhage in past 6 weeks
- Intracranial artery stenosis caused by non-atherosclerotic lesions such as arterial dissection, Moyamoya disease, vasculitis, viral vascular diseases, neurosyphilis, intracranial infections, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, CNS benign vascular disease, postpartum vascular disease, suspected vasospasm, or embolism recanalization
- History of stenting of an intracranial artery
- Presence of any definite cardiac source of embolism
- Combined intracranial tumor, aneurysm, or arteriovenous malformation
- Inability to tolerate dual antiplatelet therapy
- Contraindications to heparin, rapamycin, contrast agents, or anesthesia
- Hemoglobin less than 100 g/L or platelet count less than 100�d7109/L
- Severe liver or kidney dysfunction
- INR greater than 1.5 or uncorrectable bleeding risk factors
- Major surgery within past 30 days or planned within 90 days
- Need for simultaneous intervention of renal, iliac, or coronary arteries
- Life expectancy less than 1 year
- Pregnant or breastfeeding women
- Inability to complete follow-up due to cognitive, emotional, or mental illness
- Other conditions judged unsuitable by the investigator
- Enrollment in conflicting studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 18 locations
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
2
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
Hejian People's Hospital
Cangzhou, Hebei, China
Actively Recruiting
4
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
Actively Recruiting
5
Xingtai City Third Hospital
Xingtai, Hebei, China
Actively Recruiting
6
General Hospital of The Yangtze River Shipping
Wuhan, Hubei, China
Actively Recruiting
7
Baotou Central Hospital
Baotou, Inner Mongolia, China
Actively Recruiting
8
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China
Actively Recruiting
9
Tongliao City Hospital
Tongliao, Inner Mongolia, China
Actively Recruiting
10
Wuhai People's Hospital
Wuhai, Inner Mongolia, China
Actively Recruiting
11
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Actively Recruiting
12
The Second Norman Bethune Hospital of JilinUniversity,
Changchun, Jilin, China
Actively Recruiting
13
General Hospital of Benxi Iron and Steel Co
Benxi, Liaoning, China
Actively Recruiting
14
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Actively Recruiting
15
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
Actively Recruiting
16
The First Affiliated Hospital of College of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
17
Lishui People's Hospital
Lishui, Zhejiang, China
Actively Recruiting
18
Beilun People's Hospital of Ningbo City
Ningbo, Zhejiang, China
Actively Recruiting
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Research Team
N
Ning Ma, MD
B
Baixue Jia, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016.
GBD 2016 Stroke Collaborators
https://pubmed.ncbi.nlm.nih.gov/30871944Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis.
Marc I Chimowitz, Michael J Lynn, Harriet Howlett-Smith...
https://pubmed.ncbi.nlm.nih.gov/15800226Stenting versus aggressive medical therapy for intracranial arterial stenosis.
Marc I Chimowitz, Michael J Lynn, Colin P Derdeyn...
https://pubmed.ncbi.nlm.nih.gov/21899409Wingspan stenting for intracranial atherosclerotic stenosis: clinical outcomes and risk factors for in-stent restenosis.
Yong Sam Shin, Byung Moon Kim, Sang Hyun Suh...
https://pubmed.ncbi.nlm.nih.gov/23277374Higher risk of recurrent ischemic events in patients with intracranial in-stent restenosis.
Min Jin, Xian Fu, Yuzhen Wei...
https://pubmed.ncbi.nlm.nih.gov/23963335Multiple Mechanisms in 1 In-Stent Restenosis Assessed by Optical Coherence Tomography.
Wei-Da Lu, Chen-Wei Huang, Yi-Heng Li...
https://pubmed.ncbi.nlm.nih.gov/29102578