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| ID | Type | Description | Link |
|---|---|---|---|
| CNV202003 | Other Identifier | Medos International SARL |
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The purpose of this study is to evaluate the safety and effectiveness of CERENOVUS ENTERPRISE 2 intracranial stent implantation in treatment of participants with severe symptomatic intracranial atherosclerotic stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CERENOVUS ENTERPRISE 2 Intracranial Stent | Experimental | Participants with severe symptomatic intracranial artery stenosis will be treated with CERENOVUS ENTERPRISE 2 Intracranial Stent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CERENOVUS ENTERPRISE 2 Intracranial Stent | Device | CERENOVUS ENTERPRISE 2 Intracranial Stent will be used to treat severe symptomatic intracranial artery stenosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with In-Stent Restenosis | In-stent restenosis greater than (>) 50 percent (%) at 12 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis= ([1-{Dstenosis/Dnormal}]) * 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery. | At 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Technical Success | Technical success immediately post-procedure is defined as complete stent coverage and residual stenosis less than or equal to (<=) 50% as assessed by an independent Imaging Core Lab. | Immediately post-procedure (Day 0) |
| Number of Participants with In-Stent Restenosis |
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Inclusion Criteria:
Pre-procedure inclusion criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medos International SARL Clinical Trial | Medos International SARL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | China | ||||
| West China Hospital of Sichuan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21487117 | Background | Redon J, Olsen MH, Cooper RS, Zurriaga O, Martinez-Beneito MA, Laurent S, Cifkova R, Coca A, Mancia G. Stroke mortality and trends from 1990 to 2006 in 39 countries from Europe and Central Asia: implications for control of high blood pressure. Eur Heart J. 2011 Jun;32(11):1424-31. doi: 10.1093/eurheartj/ehr045. Epub 2011 Apr 12. | |
| 11823665 |
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Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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In-stent restenosis (>50%) at 6 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis=([1-{Dstenosis/Dnormal}]) * 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery. |
| At 6 months post-procedure |
| National Institutes of Health Stroke Scale (NIHSS) Scores | NIHSS scores at 6 months and 12 months post-procedure will be reported. NIHSS score is a tool used to objectively quantify the impairment caused by a stroke and to evaluate stroke severity. It ranges from 0 to 42, with 42 being the highest and 0 being the lowest. The higher the NIHSS score, the worse the neurological function. | At 6 months and 12 months post-procedure |
| Modified Rankin Scale (mRS) Scores | mRS scores at 30 days, 6 months and 12 months post-procedure will be reported. mRS score is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. It ranges from 0 to 5. The higher the mRS score, the worse the prognosis. | At 30 days, 6 months and 12 months post-procedure |
| Number of Participants Free of Ischemic Stroke within the Territory of Stented Vessel | Ischemic stroke within the territory of stented vessel from 30 days to 12 months post-procedure as assessed by the independent clinical events committee will be reported. | From 30 days to 12 months post-procedure |
| Chengdu |
| China |
| Haikou People's Hospital | Haikou | China |
| First Affiliated Hospital, Harbin Medical University | Harbin | China |
| Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital) | Jinan | China |
| Qilu Hospital of Shandong University | Jinan | China |
| Shandong Provincial Hospital | Jinan | China |
| Nanjing Drum Tower Hospital | Nanjing | China |
| Ningbo First Hospital | Ningbo | China |
| Huashan Hospital Fudan University | Shanghai | China |
| Wenzhou Central Hospital | Wenzhou | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| Wong KS, Li H, Lam WW, Chan YL, Kay R. Progression of middle cerebral artery occlusive disease and its relationship with further vascular events after stroke. Stroke. 2002 Feb;33(2):532-6. doi: 10.1161/hs0202.102602. |
| 16432056 | Background | Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ; Warfarin Aspirin Symptomatic Intracranial Disease Trial Investigators. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006 Jan 31;113(4):555-63. doi: 10.1161/CIRCULATIONAHA.105.578229. Epub 2006 Jan 23. |
| 19407228 | Background | Famakin BM, Chimowitz MI, Lynn MJ, Stern BJ, George MG; WASID Trial Investigators. Causes and severity of ischemic stroke in patients with symptomatic intracranial arterial stenosis. Stroke. 2009 Jun;40(6):1999-2003. doi: 10.1161/STROKEAHA.108.546150. Epub 2009 Apr 30. |
| 22182273 | Background | Fiorella D. Endovascular treatment of intracranial stenosis. World Neurosurg. 2011 Dec;76(6 Suppl):S66-70. doi: 10.1016/j.wneu.2011.07.024. |
| 17395864 | Background | Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul J, Yu SC, Forsting M, Lui M, Lim W, Sit SP. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007 May;38(5):1531-7. doi: 10.1161/STROKEAHA.106.477711. Epub 2007 Mar 29. |
| 18235078 | Background | Zaidat OO, Klucznik R, Alexander MJ, Chaloupka J, Lutsep H, Barnwell S, Mawad M, Lane B, Lynn MJ, Chimowitz M; NIH Multi-center Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology. 2008 Apr 22;70(17):1518-24. doi: 10.1212/01.wnl.0000306308.08229.a3. Epub 2008 Jan 30. |
| 21636812 | Background | Fiorella DJ, Turk AS, Levy EI, Pride GL Jr, Woo HH, Albuquerque FC, Welch BG, Niemann DB, Aagaard-Kienitz B, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG. U.S. Wingspan Registry: 12-month follow-up results. Stroke. 2011 Jul;42(7):1976-81. doi: 10.1161/STROKEAHA.111.613877. Epub 2011 Jun 2. |
| 32411409 | Background | Barnard ZR, Alexander MJ. Update in the treatment of intracranial atherosclerotic disease. Stroke Vasc Neurol. 2019 Oct 16;5(1):59-64. doi: 10.1136/svn-2019-000279. eCollection 2020. |
| 30947351 | Background | Nordmeyer H, Chapot R, Haage P. Endovascular Treatment of Intracranial Atherosclerotic Stenosis. Rofo. 2019 Jul;191(7):643-652. doi: 10.1055/a-0855-4298. Epub 2019 Apr 4. English, German. |
| Background | Tarabishy (2019). Counseling and Management of Patients with Intracranial Atherosclerosis Disease. In: Spiotta A., Turner R., Chaudry M., Turk A. (eds) Management of Cerebrovascular Disorders. |
| 32453401 | Background | Hurford R, Wolters FJ, Li L, Lau KK, Kuker W, Rothwell PM. Prognosis of Asymptomatic Intracranial Stenosis in Patients With Transient Ischemic Attack and Minor Stroke. JAMA Neurol. 2020 Aug 1;77(8):947-954. doi: 10.1001/jamaneurol.2020.1326. |
| 28017227 | Background | Zhang Q, Dong K, Song H. Comparison of stent versus medical therapy for symptomatic patients with intracranial atherosclerotic stenosis: A meta-analysis. J Neurol Sci. 2017 Jan 15;372:272-278. doi: 10.1016/j.jns.2016.11.064. Epub 2016 Nov 25. |
| 32270364 | Background | Krasteva MP, Lau KK, Mordasini P, Tsang ACO, Heldner MR. Intracranial Atherosclerotic Stenoses: Pathophysiology, Epidemiology, Risk Factors and Current Therapy Options. Adv Ther. 2020 May;37(5):1829-1865. doi: 10.1007/s12325-020-01291-4. Epub 2020 Apr 8. |
| 10782772 | Background | Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI. A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol. 2000 Apr;21(4):643-6. |
| 21729789 | Background | Chimowitz MI, Lynn MJ, Turan TN, Fiorella D, Lane BF, Janis S, Derdeyn CP; SAMMPRIS Investigators. Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial. J Stroke Cerebrovasc Dis. 2011 Jul-Aug;20(4):357-68. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.001. |
| 26823331 | Background | Bai WX, Gao BL, Li TX, Wang ZL, Cai DY, Zhu LF, Xue JY, Li ZS. Wingspan stenting can effectively prevent long-term strokes for patients with severe symptomatic atherosclerotic basilar stenosis. Interv Neuroradiol. 2016 Jun;22(3):318-24. doi: 10.1177/1591019915623797. Epub 2016 Jan 27. |
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| 21778921 | Background | Vajda Z, Schmid E, Guthe T, Klotzsch C, Lindner A, Niehaus L, Sperber W, Peters J, Arnold G, Bazner H, Henkes H. The modified Bose method for the endovascular treatment of intracranial atherosclerotic arterial stenoses using the Enterprise stent. Neurosurgery. 2012 Jan;70(1):91-101; discussion 101. doi: 10.1227/NEU.0b013e31822dff0f. |
| 28926782 | Background | Wang X, Wang Z, Ji Y, Ding X, Zang Y, Wang C. Enterprise stent in recanalizing non-acute atherosclerotic intracranial internal carotid artery occlusion. Clin Neurol Neurosurg. 2017 Nov;162:47-52. doi: 10.1016/j.clineuro.2017.06.015. Epub 2017 Jun 27. |
| 30991867 | Background | Salik AE, Selcuk HH, Zalov H, Kilinc F, Cirak M, Kara B. Medium-term results of undersized angioplasty and stenting for symptomatic high-grade intracranial atherosclerotic stenosis with Enterprise. Interv Neuroradiol. 2019 Oct;25(5):484-490. doi: 10.1177/1591019919832244. Epub 2019 Apr 16. |
| Background | Qiu, X.,Ding, Y.,Xia, S.,Li, W.,Chen, L.,Xia, X.,Ke, S.,Wei, J.,Li, Q.,Peng, Z.. Effect evaluation of Enterprise stents in the treatment of complex and severe symptomatic intracranial atherosclerotic stenosis. Chinese Journal of Cerebrovascular Diseases. 2019. 16 (5):257-262 |
| Background | Rubin, D.B., Multiple Imputation after 18+ Years. Journal of the American Statistical Association, 1996. 91(434): p. 473-489. |
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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