First clinical cases
32 Patients with high risk carotid artery lesions
12 months results
Prof. Grzegorz OszkinisPoznań (Poland) experience
More than 70% of events
after the procedureS occur
M.Bosiers
Causes of Late Embolization
Prof. Dr. Klaus Mathias, TCT 2013
• Insufficient coverage• Thrombus formation
3
MICROMESH CAROTID
stents
Page 43ROADSAVER
GORE CAROTID STENT
RoadSaver Carotid Stent
•double layer micromesh scaffold
- enabling sustained embolic protection by very tight plaque coverage
• embolic protection starts with implantation of the stent into the lesion and continues throughout the process of neointimalization
•up to 50% deployment full re-sheathable andrepositionable
Sustained Embolic Protection
•Smallest stent cell size -preventing emboli release
Tacks down/contains plaque, acting like a metallic covered stent
•Plaque coverage
Characterizes how tight the stent cells cover the plaque material, protecting it from dislodging, prolapsing/ embolizing
7
Roadsaver Stent A Stent B
Stent C Stent D Stent E
Cell Size Comparison
Micromesh(375-700 µm)
• Lesion specific scaffolding
9
•Wall apposition
The way how stent struts conform to the vesselmorphology, in combination with the radial force
(e.g. eccentric plaque: struts should not leave any dead-water zones between vessel wall and stent struts
increased thrombogenicity)
RoadSaver Carotid Stent
• 5Fr Rapid Exchange delivery system
Low profile enhances the crossability for primary stenting
• Push-Pull Stent Delivery System
For re-sheathing, a push-pull handle is necessary
• No tapered version needed
Due to the braided mesh double layer design in Nitinol, the stent nicely tapers according to the anatomy, without overstretching the vessel wall
Deployment Recapture
omeshStent Selection including MicrType Open Cells Stent Closed Cells Stent Micromesh
Name
Comp
Precise
CordisProteg
EV 3
Wallstent
BSCAdapt
BSC
Xact
Abbott
Roadsaver
TerumoCguard
Inspire
Sympto + ± +++ +++? ++ +++ +++
Asymp. +++ ++ + ++ ++ +++ +++
Bifurc. ++ +++ +++ + ± +++ +
Ulcerate ++ ++ +++ ++? +++ +++ +++
Calcifie ++ ++ + ++ +++ + ++
Short +++ +++ - ++ +++ + +++
Long ++ ++ +++ ++ + +++ +
Accurac +++ ++ + ++ +++ + +++
Irr/Coni + +++ +++ ++ +++ ++ +
Restenosis +++ +++ +++ +++ +++ +++ +++
Radioth ++ ++ +++ - +++ +++ +
Company Microvention /Terumo Inspire MD WL Gore
Material
(Stent/Micromesh)
Nitinol /Nitinol Nitinol/PET Nitinol/PTFE/
CBAS Coating
Size of delivery 5F 6F 6F
Size of Pores µ 375-500 150-180 500
Flared tips yes no no
Retrievable/Reposit
ionable
yes no no
Accuracy ++ +++ +++
Conformability +++ ++ ++
Crossability +++ ++ ++
ECA preservation yes yes Yes
EPD compatibility All All All
Summary of the main characteristic of the 3 MICROMESH stents
CGuard™ Gore CarotidRoadsaver
Details of procedure
DAPT before : All
31 Men , 9 Women : From 53 y to 85 y
1 Women : 2 stents
Asymptomatic : ALL
Sedation : NO
Femoral Approach : All
FILTER Protection : ALL
Atropine before inflation : All
Post-Dilatation : All
%N=40 Number
Procedural Events
Myocardial Infarction 0 0%
Stroke (Stent Thrombosis) 1 2,4%
Neurological Death 0 0%
30-Day Events
Myocardial Infarction 1 2,4%
Neurological Death 0 0%
Stroke 0 0%
Total
Neurological Death/Stroke/MI 2 4,8%
Procedural and 30 day Results
%N=32 Number
12 - monthsMyocardial Infarction 0 0%
Neurological Death 0 0%
Stroke 0 0%
Total after 12 months
Neurological Death/Stroke/MI 2 4,8%
12 - months Results
Asymptomatic CASRoadSaver 7x30
Asymptomatic CASRoadSaver 7x30
Plaque coverage
scaffolding
Goal: sustained embolic protection by preventing emboli release
RoadSaver 7x25
Absolute contraindications
Occluded ICA
Visible thrombus
18
CASRoadsaver 6x30
6F Destination .014 choice PT RoadSaver PTA 5x30
Roadsaver 8x30
Unmatched clinical needs?
•The ECA remains patent @ 6months !
ICAECA