2. L. Nelson Hopkins, MD DISCLOSURES Consulting Fees
Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corporation, Micrus Endovascular Cordis, a Johnson & Johnson company
Grants/Contracted Research
Cordis, a Johnson & Johnson company, Boston Scientific Corporation, Micrus Endovascular
Honoraria
AccessClosure, Inc., Bard Peripheral Vascular, Boston Scientific Corporation, Cordis, a Johnson & Johnson company, marketRx, Inc., Micrus Endovascular, Medsn
Ownership Interest (Stocks, Stock Options or Other Ownership Interest)
APW Holding, Inc., Boston Scientific Corporation, Magellan Spine Tech, Inc., MedFocus Accelerator Fund, Micrus Endovascular

3. Is Proximal Embolic Protection a Solution for High Risk CAS
Is Proximal Embolic Protection a Solution for High Risk CAS? What Does the ARMOUR Trial Tell Us?
E Levy MD
Adnan Siddiqui, MD, PhD
L N Hopkins, MD
SUNY Buffalo
Dept of Neurosurgery

4. Negative Results of CAS Trials Have Taught Us Much
Mistakes: the “Portals of Discovery”
Experience is important
Sx pts (recent) are higher risk…even with filters
Elderly pts can be dangerous
Arch disease increases risk
2/3 of strokes occur post procedure
1/5 strokes occur contralateral to CAS
Long procedures increase risk
Minor strokes usually resolve completely

5. ICSS Ischemia on MRI DWI and FLAIR Images
CAS CEA
New DWI Ischemia 46% %
1 Mo FLAIR Ischemia 30% %

6. Key Point
Carotid stenting prevents stroke
Ie. After the first 30 days

7. Annual Stroke Rate > 30 days (All Symptomatic)
CEA
CAS

8. Annual Stroke Rate > 30 days (All Symptomatic)
CEA
CAS
EVA – 3S
0.7
0.4

9. Annual Stroke Rate > 30 days (All Symptomatic)
CEA
CAS
EVA – 3S
0.7
0.4
SPACE
1.3
1.4

10. Annual Stroke Rate > 30 days (All Symptomatic)
CEA
CAS
EVA – 3S
0.7
0.4
SPACE
1.3
1.4
CREST
Lead-In
1.1

11. New technology Better pt selection Learning who NOT to stent
Identified Risk Factors: A Major Wake Up Call What We Needed What To Do ?
Better pt selection
Learning who NOT to stent
Improved technique
New technology

12. Recent Trials ARMOUR EMPIRE PROTECT EPIC All “high risk”
Death and Stroke all around 3%
All meet AHA guidelines for low risk
Proximal EP

13. CAS Risk Factors
Sx (hot) lesion…
Elderly pts…
Low GSM…
Duration Filter…
Pre dil without EP …
Tortuousity- severe…
Multiple stents…
Concentric calcium…
Aortic Arch disease…
Renal Failure...

14. CAS Risk Factors CEA Sx (hot) lesion… Elderly pts… Low GSM…
Duration Filter…
Pre dil without EP …
Tortuousity- severe…
Multiple stents…
Concentric calcium…
Aortic Arch disease…
Renal Failure...
CEA

15. Preventing Emboli

16. CEA 1)Temporary (>30min) Occl CCA, ECA & ICA 2)Open Artery …Remove Plaque 3)Close Artery…Restore Flow

17. Proximal Protection Temporary Occlusion of ECA and CCA Stent…Aspirate Debris… Restore Flow
Endovascular CEA
CCA/ ECA
CCA/ ECA/ Flow Reversal
CCA/ECA + Filter

18. proximAl pRotection with the MO.ma device
dUring caRotid stenting
Principal Investigators: Gary Ansel - Columbus (OH) L. Nelson Hopkins – Buffalo (NY)

19. Overview Proximal Flow Blockage Cerebral Protection Device
CCA clamping: blockage of antegrade blood flow
ECA clamping: blockage of retrograde blood flow
Debris removal: syringe blood aspiration 5 10 15 20

20. Overview 6F I.D. fully usable Working Channel 9F O.D. shaft
Guiding Sheath integrating 2 compliant balloons
6F I.D. fully usable Working Channel
9F O.D. shaft

21. Key Facts high system stability and back-up support
Guiding sheath with 2 anchoring balloons
high system stability and back-up support
guide wire of choice to cross the lesion
Lesion crossing under protection
No need for suitable landing zone in the distal diseased ICA
All type and size debris aspiration

22. Results 2° Endpoint (ITT)
MO.MA Device Success 98.2%
Technical Success 94.6%
Procedural Success 93.2%
Restenosis at 30 days 1.6%
TLR at 30 days 0%
Access Site Complications 3.1%

23. Endovascular Clamping Intolerances
CEC adjudicated: unresolved clamping intolerances, TIAs and Strokes
29 “Resolved”
all without TIA (<5 minutes)
2 “Unresolved”: TIA + 1 Minor Stroke on the day of the procedure
ARMOUR Study definitions of Endovascular Clamping Intolerances:
Resolved Intolerance: temporary symptoms lasting < 20 min. after declamping
Unresolved Intolerance: temporary symptoms lasting > 20 min. after declamping

24. Serious Adverse Events
Site reported SAE = 16.4% of subjects (ITT)
No (0%) Unanticipated Adverse Device Effects (UADE)

25. Results 1° Endpoint 30d Results (ITT & Full Population)
30d Results by Symptoms and Age (ITT)

26. EMPiRE Major Adverse Event Rates
* Includes TIA – not typically included in CAS MAE rate

27. EMPiRE Major Adverse Event Rates by Subgroup (Stroke, Death, MI)

28. Carotid Stent Trials* 30d Event Rates
* Study parameters and “Event” definitions may vary per clinical trial

29. Proximal Embolic Protection Conclusions
Contrary to popular opinion… EASY TO USE
Intolerance is rare… and usually reversible
Less emboli get to brain… MRI & TCD
Procedure of choice for:
Recent sx
Low GSM, long ulcerative lesions
Perilesional kinks
String sign
Acute carotid occlusion/ stroke
Luminal thrombus

30. Ischemic Stroke
We Are On To Something !

31. Endovascular Endarterectomy !!

33. Thank You!