審査報告書（案）
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1
2 MI BZY mm CEA 59 mm 2
3 50%
4 [ ] 7 [ ] [ ] [ ] [ ] [ ] CEA 49mm
![18 6 28 [ ]](/docs-images/42/22899189/images/page_4.jpg "CEA 49mm 50 80")
5 carotid endarterectomy CEA 1,2 CEA ECST 3 NASCET 4 ACAS 5 5
6 CEA CEA carotid artery stenting CAS CAS SMART 1998 SMART 1999 XP Angioguard XP ****** MDR Medical Device Reporting 0.122%**** 0.016%** 0.012%** 0.010%** 0.44% 0.071% 6
7 0.061%: % 0.007% CAS MRI ***** 10 ************** 7
8 ************************* 41 3 MRI BZY BX 21300BZY
9 21600BZY Fr 6 Fr SMART Fr 6Fr 26 SMART 52 1 SMART 26 9
10 EN1441 Risk Analysis of Medical Devices EN-ISO Medical Devices- Risk Management FDA MRI SAPPHIRE Angioguard 2 CASCADE Study Angioguard 30 Angioguard 10%(9/90) 3.1%(1/32) Feasibility Study 60% 80%
11 30 Major Adverse EventMAE: 6.9%(18/261) MAE( ) 10.7%(28/261) 1 MAE Angioguard 12.5%(22/176) 7.1%(6/85) Angioguard MAE SAPPHIRE CEA CAS (167 )CEA (167 ) CEA 406 CEA CAS 7 CEA SMART SMART CEA CAS CEA MAE 30 MI MAE 360 MAE 360 MAE CAS CEA 30 MAE 4.8 8/167 CEA /167P= MAE /167 CEA /167P= CEA 360 MAE 11
12 (Objective Performance Criteria OPC) MAE / /406 OPC 30% MAE ) / / ( 50% ) /122 CEA /96 P= CEA 4.3 P= % (78/282) 0.8% 1 SAPPHIRE CEA P N=167N=167 N= %(140/159) N/A N/A 87.9%(355/404) 91.2%(145/159) N/A N/A 89.6%(363/405) 95.6%(152/159) N/A N/A 91.6%(372/406) 19.7%(24/122) 31.3%(30/96) %(78/282) 15.6%(19/122) 13.5%(13/96) %(52/282) TLR 0.60% 4.30% % MAE 12.20% 20.10% % 30 MAE 4.8%(8/167) 9.6%(16/167) %(28/406) 1.2%(2/167) 2.4%(4/167) %(9/406) MI 2.4%(4/167) 6.0%(10/167) %(7/406) 3.6%(6/167) 3.0%(5/167) %(20/406) 360 MAE 12.0%(20/167) 19.2%(32/167) %(64/406) 7.2%(12/167) 12.6%(21/167) %(41/406) 6.0%(10/167) 7.2%(12/167) %(37/406) 0.6%(1/167) 3.0%(5/167) %(13/406) 3.6%(6/167) 1.8%(3/167) %(16/406) 9.0%(15/167) 10.2%(17/167) %(54/406) %29/167 CEA 12
13 3.0%5/167 CEA P< %14/167 CEA 3.0%5/167 p= % 63/ %14/406 CEA p= CEA P N=167N=167 N= %(15/167) 10.2(17/167) %(52/406) 17.4%(29/167) 3.0%(5/167) %(61/406) 8.4%(14/167) 3.0%(5/167) %(13/406) 0.0%(0/167) 4.2%(7/167) %(0/406) %(15/167) 10.2%(17/167) %(54/406) 17.4%(29/167) 3.0%(5/167) %(63/406) 8.4%(14/167) 3.0%(5/167) %(14/406) 0.0%(0/167) 4.8%(8/167) %(0/406) SAPPHIRE OPC 13
14 6. 3 CAS CEA 1. ( ) 2. (TCD; Transcranial doppler sonography) SAPPHIRE CEA FDA
15 360 MAE CEA 5. CEA OPC CEA MAE CEA CEA CEA CEA CCS III IV 6. SAPPHIRE 3 MAE 26.2 CEA 30.3 P= CEA CEA CEA SAPPHIRE SAPPHIRE CEA CEA 360 MAE CEA OPC CEA OPC CEA OPC CEA propensity score analysis CEA 15
16 SAPPHIRE CEA CAS CEA CEA CAS CEA CAS CEA CEA CEA CASCEA CAS CEA CEA ******* (10 76 ) 60 SMART 81.8%63/ / / / / /76 SAPPHIRE 16
17 SAPPHIRE CEA 60% CAS CEA SAPPHIRE CEA CEA CEA SAPPHIRE CEA 50% 60% CEA 80% 2% 80% 5% 80% CEA 50% 80% CEA CEA SAPPHIRE CAS CEACAS 17
18 510mm 5mm 5mm 5mm 5mm 3 5mm 5mm 14 5 GCP 14 5 GCP GCP GCP QMS
19 CEA CEA CAS 1. CEA CAS CEA CAS CEA CAS CEA CEA CEA CAS CEA CEA 2. / CEA CAS 19
20 CEA 59 mm 50%
21 Philip A, et al. Preventing Ischemic Stroke in Patients With Prior Stroke and Transient Ischemic Attack. A Statement for Healthcare Professionals From the Stroke Council of the American Heart Association. Stroke 30: , European Carotid Surgery Trialist s Collaborative Group : MRC European Carotid Surgery Trial : Interim results for symptomatic patients with severe (70-99%) or with mild (0-29%) carotid stenosis. Lancet 337 : , North American Symptomatic Carotid Endarterectomy Trial Collaborators : Beneficial effect of carotid endarterectomy in symptomatic patients with high grade carotid stenosis. N Engl J Med 325 : , Endarterectomy for asymptomatic carotid artery stenosis. Exective Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA 273 : ,
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第18回海岸シンポジウム報告書
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症例報告 JNET 5:195-201, 2012 FilterWire EZ を用いたステント留置術中に no flow を来した 1 例 : 症例報告 No flow phenomenon during carotid artery stenting with the use of FilterWire EZ: a case report Masao MORIY Hiroshi ITOKW Michio
