Correct stent selection in symptomatic carotid artery

diseaseKoen Deloose, MD

Head Dpt Vascular Surgery

AZ Sint Blasius, Dendermonde, Belgium

2iD3 Medical – 2017 |

Case presentation : 74yr, male

• Medical history 2007 Right FP1-bypass

2010 CABG

2015 PTAS left SFA

2016 DCB distal anastomosis right bypass

• Risk factorsSmoking, hypercholesterolemia

• Present stateSpeech difficulties & numbness right arm/hand during 8

hours, completely recovered afterwards

3iD3 Medical – 2017 |

Case presentation : 74yr, male

• Duplex ultrasound Peak systolic velocities ~ 450 cm/sec

mixed lipid-fibrotic plaque, moderate

echolucent, GSM < 15

• Diffusion weighted MRIshows a frontal subcortical high signal

intensity lesion

4iD3 Medical – 2017 |

Case presentation : 74yr, male

• MRI angio carotid vessels

• What to do?

5iD3 Medical – 2017 |

Case presentation : 74yr, male

• What to do?

• CAS – CEA – Anti-platelet therapy?

• If CAS, access?

• If CAS, protected or unprotected? Which EPD? Which guide wire?

• Predilation? Protected? Unprotected?

• If CAS, which stent? Why?

6iD3 Medical – 2017 |

Case presentation : 74yr, male

• What to do?

• CAS

• Right femoral access

• JB2 catheter (Cordis°) with soft, curvedGlidewire 035”, 260 cm (Terumo°)

• Discovery 740 + Vessel Assist (GE°)

7iD3 Medical – 2017 |

Vessel ASSIST offers a Bi-view registration mode:

3D model registration with 2 simultaneous displayed, different angled (Accuracy Score), fluoroscopic images

2D-3D Registration at tableside by translating/rotating on correct landmarks (Calcium, bone, previous stents…)

GUIDE YOUR PROCEDURE WITH VESSEL ASSIST

8iD3 Medical – 2017 |

Vessel ASSIST offers a Bi-view registration mode:

2D-3D Registration at tableside by translating/rotating on correct landmarks (Calcium, bone, previous stents…)

Getting access to the left CCA and position a stable 6F, 90 cm Destination sheath (Terumo°)

GUIDE YOUR PROCEDURE WITH VESSEL ASSIST

9iD3 Medical – 2017 |

Case presentation

• Destination 6F, 90cm (Terumo°)

• Spartacore 0,014” (Abbott Vascular°)

• Option for direct stenting, no EPDWHICH ONE ???

10iD3 Medical – 2017 |

Case presentation

• Roadsaver 8-30 (Terumo°)

11iD3 Medical – 2017 |

Case presentation

• Roadsaver 8-30 (Terumo°)

12iD3 Medical – 2017 |

Case presentation

• Patient stayed 60’ on recovery room

• Stayed overnight in the hospital

• Discharged 28 hours after procedure without anyneurological event and a perfect wall appositionedand patent stent

• Post procedural medication : Clopidogrel – ASA for3 months, afterwards lifelong ASA monotherapy

• FU : 1m, 6m, 12m, 24m, 36m

Room for periproceduralimprovement D0 -> D31

Free

do

mo

f M

AN

E

t

OK !

Timeline (days)

We need better protection againstSMALL & LATE embolisation

14iD3 Medical – 2017 |

We need better protectionagainst SMALL & LATE emboli…

15iD3 Medical – 2017 |

Roadsaver Stent (Terumo)

• Nitinol interwoven stent (180 µm struts) covering a woven mesh of thinner nitinol wires (42 µm). Additionally, inner mesh and outer stent are connected on several spots with 45 µm thick wires : pore size 375µm

16iD3 Medical – 2017 |

…We need a sustained “embolicprotection device”….

With the courtesy of Stephan Muller Hulsbeck, presented @LINC 2017, Leipzig, Germany

375 µ 500µ1050µ

Closed cell stent

1900µ Open cell

stent

ROADSAVER

17iD3 Medical – 2017 |

CLEAR-ROAD study

Primary Endpoint30-day rate of Major Adverse Events (MAE), defined as thecumulative incidence of any peri-procedural death, stroke or myocardial infarction (≤30 days post-procedure)

Secondary Endpoints• Late ipsilateral stroke (D31 – D365)

• Technical succes rate & device malfunctions

• MAE by sub-group symptomatic/asymptomatic

• TLR – ISR

18iD3 Medical – 2017 |

Per Protocol MAE’s

All Death, Stroke, or MI 2.00%

Death 1.00%

Any Stroke 1.00%

- Major Stroke 0.00%

- Minor Stroke 1.00%

MI 0.00%

Results – 30 daysPrimary Endpoint: 30-day rate of MajorAdverse Events (MAE), defined as thecumulative incidence of any peri-procedural death, stroke* or myocardialinfarction (≤30 days post-procedure)

*Stroke is defined as an acute neurologic event with localsymptoms and signs lasting more than 24 hours consistentwith focal cerebral ischemia.

1 patient died at Day 4.

1 patient experienced an ipsilateralstroke (Day 12) because of AF and

inadequately anticoagulantia medication.

97.9%

19iD3 Medical – 2017 |

12-month freedom from MAE

90.7%

Ipsilateral Stroke 4 patients

Contralateral Stroke 1 patients

Death- due to M.I.- due to kidney failure

3 patients- 2 patients- 1 patient

20iD3 Medical – 2017 |

12-month freedom fromipsilateral stroke

time baseline 30 days 6MFU 12MFU Significant

Symptomaticat risk 31 30 29 28

P = 0.7797

% 100 100 100 96.6

Asymptomaticat risk 69 66 65 59

% 100 98.6 98.6 95.5

21iD3 Medical – 2017 |

12-month patency and TLR

92.5%

12 month Primary Patency is 92.5%

97.9%

12 month freedom from TLR is 97.9%