Clinical Trials

Intra-arterial Thrombolysis After Successful Thrombectomy for Acute Ischemic Stroke Due to Large Vessel Occlusion in the Posterior Circulation (IAT-TOP)  

Prof. Raul G. Nogueira
Prof. Wenhuo Chen

Study started April 2023, Ongoing

ClinicalTrials.gov Identifier: NCT05897554

ClinicalTrials.gov: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.

Keywords:

Intra-arterial thrombolysisAlteplaseLarge vessel occlusionMechanical thrombectomyEndovascular treatment

Relevant article:

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.


Prof. Liqun Jiao

Extracranial-intracranial Bypass Surgery Versus Medical Treatment Alone for Symptomatic Chronic Middle Cerebral Artery Occlusion(CMOSS-2)

Prof. Yuxiang Gu

Prof. Colin P. Derdeyn

Study started April 2023, Ongoing ClinicalTrials.gov Identifier: NCT05899582 ClinicalTrials.gov: 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. Keywords: Middle cerebral artery occlusion, stroke,TIA Relevant article: 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.

Prof. Yan Ma
Prof. Liqun Jiao

Drug-eluting Stenting Versus Medical Treatment Alone for Patients With Extracranial Vertebral Artery Stenosis(VISTA)

Prof. Hugh Stephen Markus

Study started April 2023, Ongoing

ClinicalTrials.gov Identifier: NCT05885932

ClinicalTrials.gov: 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.

Keywords:

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

Relevant article:

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.


Prof. Huaizhang Shi
Prof. Liqun Jiao

The Carotid and Middle Cerebral Artery Occlusion Surgery Study (CMOSS)

Prof. Yuxiang Gu
Study started January 2013, Completion May 2020
ClinicalTrials.gov Identifier: NCT01758614
ClinicalTrials.gov:

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.

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

Relevant article:
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
Prof. Yan Ma

China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS)

Prof. Daming Wang
Study started January 2013, Completion May 2020
ClinicalTrials.gov Identifier: NCT01763320 ClinicalTrials.gov:https://clinicaltrials.gov/ct2/show/NCT01763320?term=CASSISS&draw=2&rank=1

The purpose of this study is to compare stenting in high-volume center with best medical therapy in subjects with symptomatic intracranial artery stenosis.
CASSISS is an ongoing, government-funded, prospective, multicenter randomized trial. The CASSISS will compare the incidence rate of stroke or death within 30 days after enrollment and any stroke, death in the territory of the symptomatic intracranial artery beyond 30 days through 12 months between the stenting arm and the control arm in subjects with symptomatic intracranial artery stenosis. Keywords: Atherosclerosis, intracranial stenosis, stroke, angioplasty and stenting, China Relevant article: Gao P, Zhao Z, Wang D, et al. China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China. Interv Neuroradiol. 2015;21(2):196-204. doi:10.1177/1591019915581778 Gao P, Wang D, Zhao Z, et al. Multicenter Prospective Trial of Stent Placement in Patients with Symptomatic High-Grade Intracranial Stenosis. AJNR Am J Neuroradiol. 2016;37(7):1275-1280. doi:10.3174/ajnr.A4698
Prof. Liqun Jiao

Revascularization of Extracranial Carotid Artery Stenosis (RECAS)

Prof. Bo Hong
Study started November 2013, Completion February 2016 ClinicalTrials.gov Identifier: NCT01994187 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.

Keywords: Carotid artery stenosis, Carotid artery stenting, Carotid endarterectomy, Stroke
Relevant article: 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


Prof. Liqun Jiao

Clinical Registration Trial of Intracranial Stenting for Patients with Symptomatic Intracranial Artery Stenosis (CRITICAS)

Prof. Huaizhang Shi

Study started November 2013, Completion December 2015 ClinicalTrials.gov Identifier: NCT01994161 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.


Keywords:
Intracranial artery stenosis, Intracranial artery stenting, Stroke, China

Prof. Liqiao Jiao
Academic Advisor
Dr. Colin P Derdeyn
Dr. Raul G Nogueira
Dr. David S Liebeskind
Dr. Hugh S Markus
Dr. William J Powers
Tel:

+8615633140085(Site Manager:Dr.Shengyan Cui)

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Xicheng District, Beijing, China

Email:

crcoffical@163.com  

wangtao_dr@sina.com  (Team Manager Dr.Wang Tao)

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