临床试验

急性后循环大血管闭塞机械取栓成功再通后动脉内阿替普酶桥接治疗的安全性及有效性:前瞻性、多中心、开放标签、随机对照研究 (Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion in the Posterior Circulation IAT-TOP研究)

Raul G. Nogueira教授
陈文伙教授

试验启动于2023年4月,进行中

ClinicalTrials.gov 注册号: NCT05897554

ClinicalTrials.gov注册网址:

https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000D9QP&selectaction=Edit&uid=U00053OC&ts=5&cx=h8aimx

The IAT-TOP trial is a government-funded, prospective, multicenter, randomized controlled trial. Patients will be randomized (1:1) to intra-arterial rt-PA group or without intra-arterial rt-PA group. Primary outcome is the rate of modified Rankin Scale score of 0-2 within 90 days after randomization. The IAT-TOP trial will be conducted in 34 sites in China.

关键词:

Intra-arterial thrombolysisAlteplaseLarge vessel occlusionMechanical thrombectomyEndovascular treatment

相关文献:

Adusumilli G, Kobeissi H, et al. Endovascular thrombectomy after acute ischemic stroke of the basilar artery: a meta-analysis of four randomized controlled trials. J Neurointerv Surg. 2023 Dec 21;15(e3):e446-e451. doi: 10.1136/jnis-2022-019776. PMID: 36597942.

Renú A, Millán M, et al. CHOICE Investigators. Effect of Intra-arterial Alteplase vs Placebo Following Successful Thrombectomy on Functional Outcomes in Patients With Large Vessel Occlusion Acute Ischemic Stroke: The CHOICE Randomized Clinical Trial. JAMA. 2022 Mar 1;327(9):826-835. doi: 10.1001/jama.2022.1645. PMID: 35143603; PMCID: PMC8832304.


焦力群教授

颅内外血管搭桥手术治疗症状性大脑中动脉慢性闭塞的多中心随机对照研究(Extracranial-intracranial Bypass Surgery Versus Medical Treatment Alone for Symptomatic Chronic Middle Cerebral Artery Occlusion CMOSS-2研究)

顾宇翔教授

Colin P. Derdeyn

教授

试验启动于2023年4月,进行中 ClinicalTrials.gov 注册号: NCT05899582 ClinicalTrials.gov 注册网址:

https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S000D9N3&selectaction=Edit&uid=U00053OC&ts=5&cx=-8ug04h The CMOSS-2 trial is a government-funded, prospective, multicenter, randomized controlled trial. It will recruit symptomatic chronic occlusion of the middle cerebral artery in patients with severe hemodynamic insufficiency. Only high-volume center with a proven track record will be included. Patients will be randomized (1:1) to best medical treatment alone or medical treatment plus bypass surgery. Primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization. The CMOSS-2 trial will be conducted in 13 sites in China. 关键词: Middle cerebral artery occlusion, stroke,TIA 相关文献: Ma Y, Wang T, et al. CMOSS Investigators. Extracranial-Intracranial Bypass and Risk of Stroke and Death in Patients With Symptomatic Artery Occlusion: The CMOSS Randomized Clinical Trial. JAMA. 2023 Aug 22;330(8):704-714. doi: 10.1001/jama.2023.13390. PMID: 37606672; PMCID: PMC10445185.

Gao P, Wang T, et aal. CASSISS Trial Investigators. Effect of Stenting Plus Medical Therapy vs Medical Therapy Alone on Risk of Stroke and Death in Patients With Symptomatic Intracranial Stenosis: The CASSISS Randomized Clinical Trial. JAMA. 2022 Aug 9;328(6):534-542. doi: 10.1001/jama.2022.12000IF: 120.7 Q1 . PMID: 35943472; PMCID: PMC9364128. Powers WJ, Clarke WR, et al. COSS Investigators. Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial. JAMA. 2011 Nov 9;306(18):1983-92. doi: 10.1001/jama.2011.1610. Erratum in: JAMA. 2011 Dec 28;306(24):2672. Obviagele, Bruce [corrected to Ovbiagele, Bruce]. PMID: 22068990; PMCID: PMC3601825.

马妍教授
焦力群教授

药物洗脱支架治疗椎动脉颅外段狭窄多中心随机对照研究( Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis VISTA 研究)

Hugh Stephen Markus 教授

试验启动于2023年4月,进行中

ClinicalTrials.gov 注册号: NCT05885932

ClinicalTrials.gov 注册网址:

https://clinicaltrials.gov/ct2/show/NCT05885932?cond=Drug-eluting +Stenting+Versus+Medical+Treatment+Alone+for+Patients+With+Extracranial+Vertebral+Artery+Stenosis&draw=2&rank=1

The drug-eluting stenting versus medical therapy alone for patients with extracranial vertebral artery stenosis (VISTA) trial, is a government-funded, prospective, multicenter, randomized controlled trial. It will recruit patients with 3 months stroke or TIA caused by 70-99% stenosis of extracranial vertebral artery (V1-2 segments). Patients will be randomized (1:1) to best medical treatment alone or medical treatment plus stenting. Primary outcome is a composite of any fatal or non-fatal stroke within 30 days after randomization, or ischemic stroke in the territory of the target artery beyond 30 days to 1 year.  Recruitment is expected to be finished by Sep, 2025. The first stage of the trial is scheduled to complete in 2027.

关键词:

Extracranial vertebral artery stenosis, Drug-eluting stenting, Best medical treatment, Ischemic stroke.

相关文献:

Compter A, et al. VAST investigators. Stenting versus medical treatment in patients with symptomatic vertebral artery stenosis: a randomised open-label phase 2 trial. Lancet Neurol. 2015 Jun;14(6):606-14. doi: 10.1016/S1474-4422(15)00017-4. Epub 2015 Apr 20. PMID: 25908089.

Turan TN, Zaidat OO, et al. Stroke Prevention in Symptomatic Large Artery Intracranial Atherosclerosis Practice Advisory: Report of the AAN Guideline Subcommittee. Neurology. 2022 Mar 22;98(12):486-498. doi: 10.1212/WNL.0000000000200030IF: 9.9 Q1 . PMID: 35314513; PMCID: PMC8967328.

Markus HS, Larsson SC, et al. VIST Investigators. Stenting for symptomatic vertebral artery stenosis: The Vertebral Artery Ischaemia Stenting Trial. Neurology. 2017 Sep 19;89(12):1229-1236. doi: 10.1212/WNL.0000000000004385IF: 9.9 Q1 . Epub 2017 Aug 23. PMID: 28835400; PMCID: PMC5606920.


史怀璋教授
焦力群教授

颈动脉和大脑中动脉闭塞手术研究(The Carotid and Middle Cerebral Artery Occlusion Surgery Study CMOSS研究)

顾宇翔教授
试验于2013年1月开始,于2020年5月结束
ClinicalTrials.gov 注册号: NCT01758614
ClinicalTrials.gov 注册网址:

The study is designed to compare the efficacy and safety of EC-IC bypass surgery with medical therapy in patients with symptomatic hemodynamically significant carotid occlusion.

CMOSS is an ongoing, government-funded, prospective, multicenter, randomized trial. The CMOSS will compare the incidence rate of all stroke or death within 30 days after enrollment and ipsilateral ischemic stroke within 24 months of randomization between the bypass group and the medical group in subjects with symptomatic hemodynamically significant carotid occlusion.

关键词:
Carotid artery, Middle cerebral artery, Occlusion, Hemodynamic, Bypass surgery, Ischemic stroke, China

相关文章:
Ma Y, Gu Y, Tong X, et al. The Carotid and Middle cerebral artery Occlusion Surgery Study (CMOSS): a study protocol for a randomised controlled trial. Trials. 2016;17(1):544. Published 2016 Nov 16. doi:10.1186/s13063-016-1600-1
马妍教授

中国血管成形术和支架植入术治疗症状性颅内重度狭窄研究(China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis CASSISS研究)

王大明教授
试验于2013年1月开始,于2020年5月结束
ClinicalTrials.gov 注册号: NCT01758614
ClinicalTrials.gov 注册网址:

The study is designed to compare the efficacy and safety of EC-IC bypass surgery with medical therapy in patients with symptomatic hemodynamically significant carotid occlusion.

CMOSS is an ongoing, government-funded, prospective, multicenter, randomized trial. The CMOSS will compare the incidence rate of all stroke or death within 30 days after enrollment and ipsilateral ischemic stroke within 24 months of randomization between the bypass group and the medical group in subjects with symptomatic hemodynamically significant carotid occlusion.

关键词:
Carotid artery, Middle cerebral artery, Occlusion, Hemodynamic, Bypass surgery, Ischemic stroke, China

相关文献:
Ma Y, Gu Y, Tong X, et al. The Carotid and Middle cerebral artery Occlusion Surgery Study (CMOSS): a study protocol for a randomised controlled trial. Trials. 2016;17(1):544. Published 2016 Nov 16. doi:10.1186/s13063-016-1600-1
焦力群教授

颅外颈动脉狭窄的血运重建研究 (Revascularization of Extracranial Carotid Artery Stenosis RECAS研究)

洪波教授
试验于2013年11月开始,于2016年2月结束 ClinicalTrials.gov 注册号: NCT01994187 ClinicalTrials.gov 注册网址:
https://clinicaltrials.gov/ct2/show/NCT01994187?term=NCT01994187&draw=2&rank=1
The study is designed to evaluate the safety outcome profile of CEA and CAS in Chinese patients with carotid artery stenosis.
RECAS is a multicenter, prospective cohort study. The RECAS will explore the incidence rate of stroke (ischemic or hemorrhagic), death or cardiovascular events within 30 days and beyond 30 days to 12 months after any revascularization procedure.

关键词: Carotid artery stenosis, Carotid artery stenting, Carotid endarterectomy, Stroke
相关文献: Yang B, Ma Y, Wang T, et al. Carotid Endarterectomy and Stenting in a Chinese Population: Safety Outcome of the Revascularization of Extracranial Carotid Artery Stenosis Trial [published online ahead of print, 2020 Jul 19]. Transl Stroke Res. 2020;10.1007/s12975-020-00835-8. doi:10.1007/s12975-020-00835-8


焦力群教授

颅内支架置入术治疗症状性颅内动脉狭窄临床注册试验(Clinical Registration Trial of Intracranial Stenting for Patients with Symptomatic Intracranial Artery Stenosis CRITICAS研究)

史怀璋教授

试验于2013年11月开始,于2015年12月结束 ClinicalTrials.gov 注册号: NCT01994161 ClinicalTrials.gov 注册网址:

https://clinicaltrials.gov/ct2/show/NCT01994161?term=NCT01994161&draw=2&rank=1

The study is designed to observe the safety and effectiveness of intracranial stenting for preventing stroke during a mean follow-up of 3 years in patients with symptomatic stenosis of a major intracranial artery (MCA, carotid, vertebral, basilar).

CRITICAS is a prospective, government-funded registration study. The CRITICAS will explore the incidence rate of ischemic stroke, death or cardiovascular events after enrollment or any revascularization procedure of the qualifying lesion in the territory of the symptomatic intracranial artery.


关键词:
Intracranial artery stenosis, Intracranial artery stenting, Stroke, China

焦力群教授
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Dr. Colin P Derdeyn
Dr. Raul G Nogueira
Dr. David S Liebeskind
Dr. Hugh S Markus
Dr. William J Powers
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