Micromesh stent technology – also a solution for peripheral

arteries?

Dr Daniel Périard Angiology

Hôpital Cantonal Fribourg

Switzerland

Disclosure

I have no potential conflict of interest regarding this

presentation.

RoadSaver ™ carotid stent

It is a double layer of braided nitinol wires

The outer layer provides high radial force, flexibility and conformation to tortuous anatomy

The inner micromesh layer has the smallest cell size, preventing plaque protrusion and embolism

5Fr rapid exchange platform

Fully re-sheathable and repositionable

(1) Am J Cardiol. 2015 Sep 15;116(6):977-81. doi: 10.1016/j.amjcard.2015.05.063. Epub 2015 Jun 25. (2) Tailored carotid artery stenting, Pieniazek et al., J. Endovasc. Ther. (3) A novel carotid stent for sustained embolic protection, Subbarao Myla, Newport Beach, USA, Presentation CIRSE 14.-18.September 2013, Barcelona, Spain (4) Safety of Slender 5Fr Transradial Approach for Carotid Artery Stenting With a Novel Nitinol Double-Layer Micromesh Stent. Kedev S., et al., Am J Cardiol. 2015 Sep 15;116(6):977-81. doi: 10.1016/j.amjcard.2015.05.063. Epub 2015 Jun 25. (5) Initial clinical experience with the micromesh roadsaver carotid artery stent for the treatment of patients with symptomatic carotid artery disease. Hopf-Jensen S, et al., J Endovasc Ther. 2015 Apr;22(2):220-5. doi: 10.1177/1526602815576337. (6) Cremonesi A et al. Carotid Artery Stenting an update EHJ2015 (7) Deloose, K. et al.,Clinical Evidence for Roadsaver Carotid Stent the CLEAR-ROAD trial, CIRSE 2014 (8) Amor, M. et al. Pre-Clinical and first clinical experiences with the Micromesh Carotid stent Roadsaver, LINC 2014

Italian Registry 3 Centers:

Cremonesi/ Castriota (Cotignola) Setacci/ Cappelli (Siena) Rabbia/ Ruffino (Turin)

> 150 Patients enroled Results

No complications No plaque prolapse Fewer and smaller new white lesions compared to C-Guard, diagnosed by DW-MRI

Clearroad Trial 9 Centers

Peeters (Bonheiden), Bosiers/ Deloose (Dendermonde), Maene (Aalst), Setacci/ Cappelli (Siena), Langhoff (Berlin), Müller-Hülsbeck (Flensburg), Sievert (Frankfurt), Scheinert/ Schmidt (Leipzig), Torsello/ Schwindt (Münster)

81 patients enroled

Results (preliminary)

No stroke

1 MI

Ongoing studies evaluating the Roadsaver ™ for CAS

open cell laser-cut nitinol stent may

be unable to achieve a good lumen

patency and lack of resistance to

high external compression

result after multiple in-

stent angioplasties

RoadSaver ™

The Roadsaver ™ micromesh stent for SFA/popliteal extremely calcified lesions:

a pilot study Monocentric study

Investigator initiated

Inclusion criteria:

• PAD with severely calcified SFA/pop lesions

• At least one run off vessel before Roadsaver ™ implantation

Objectives: technical aspects

success of implantation

security of the Roadsaver ™

efficacy of the Roadsaver ™

Follow-up: clinical examination and duplex scan 1, 6, 12, 18, 24 M

The Roadsaver ™ micromesh stent for SFA/popliteal extremely calcified lesions

Inclusion current status (started May 2015) :

baseline characteristics patients n=21

age (y) 75 ± 11

gender (male) 67%

diabetes 38%

hypertension 81%

smoking (past or current) 43%

hyperlipidemia 62%

renal failure (ClCr ≤ 30 ml/min) 14%

Rutherford 3 or 4 52%

5 9.5%

6 14%

The Roadsaver ™ micromesh stent for SFA/popliteal extremely calcified lesions

Lesions characteristics:

patients n=21

SFA 71%

poplitea 67%

calcifications mild 33%

heavy (>180°) 6 (30 %)

massive (360°) 33%29%

mean degree of stenosis 89±11 %

occlusions 48%

sub-intimal recanalisation 14%

treated lesion lenght (PTA) (mm) 169±129 mm

stented segment lenght (mm) 35±9 mm

debulking 19%

patients n=21 procedure primary success

100 %

30 days primary patency 100%

30 days freedom from TLR 100%

30 days freedom from TVR 96% *

patients n=15

6 months primary patency 100 %

6 months in stent restenosis (PSV≥2) 0 %

* recanalisation of a lesion proximal to the Roadsaver

The Roadsaver ™ micromesh stent for SFA/popliteal extremely calcified lesions

Results:

Immediate result of

the Roadsaver™

implantation no restenosis at 6 months Duplex

84 y woman, rutherford 4

The Roadsaver ™ may be used as a flow diverter for small poplitea aneurysm. High plaque coverage operates as a metallic covered stent, but keeps the side branch open

Popliteal calcified

stenosis with post-

stenotic small

aneurysm

Roadsaver™ used

as a scaffold for

the stenosis and

flow diverter for

the aneurysm

Thrombosis of the

aneurysm and

preserved flow in

the stent and the

side branch

day 0 day 18

76 y man, rutherford 3

conclusions

Innovative dual layer stent with excellent scaffold for SFA/pop calcified lesions.

Safe

Ease of use

Absence of restenosis at 6 months

Candidate for popliteal aneurysm cure (flow diverter)

Further studies must confirm these results

Micromesh stent technology – also a solution for peripheral

arteries?

Dr Daniel Périard Angiology

Hôpital Cantonal Fribourg

Switzerland