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

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 : ,

JCAS 対象および方法 prospective registry CEA CAS JCAS RCT 2 JCAS TIA minor stroke major stroke mrs CEA CAS 1 3 SPECT case volume CEA CAS 結果

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Online publication October 3, 2011 原 著 第 51 回総会座長推薦論文 内頸動脈起始部狭窄病変における収縮期加速時間の有用性 要 旨 : acceleration time; AcT AcT AcT 110 msec NASCET 60 Online publication October 3, 2011 原 著 第 51 回総会座長推薦論文 内頸動脈起始部狭窄病変における収縮期加速時間の有用性 1 2 3 要 旨 : acceleration time; AcT 137 266 AcT AcT 110 msec NASCET 60 AcT J Jpn Coll Angiol, 2011, 51: 365 371 Key words:

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