Post on 29-Jan-2021
transcript
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