Prospective, Multicenter, Post-market, Single Arm study to confirmthe performance of the RenzanTM Peripheral Stent System in treating Superficial Femoral and/or Popliteal artery disease

Peripheral arterial disease (PAD) is a progressive disorder caused by
atherosclerotic changes in the blood vessel wall, which result in stenosis or
occlusion of the arteries outside the heart and brain [1]. The pathology
affects >200 million people worldwide [2, 3]. During the preceeding decade
alone the number of PAD-affected individuals increased by 13% in high- and by
29% in low-income countries [3]. The PAD prevalence increases with age,
affecting >20% of octogenarians (>80-year-old individuals) [1-3]. Lower
extremity PAD is its most common subset [1]. It manifests a broad spectrum of
symptoms ranging from none to recurrent fatigue or pain/cramping with walking
(i.e. intermittent claudication). At more advanced disease stages, referred to
as critical limb threatening ischemia (CLI), the rest pain and tissue loss
(ulcerations and/or gangrene) are observed. PAD is associated with high
morbidity and both cardiovascular and all-cause mortality rates. The pathology
causes major personal, medical and socio-economic burden, increasingly becoming
a global healthcare concern [1-4].

Patients with asymptomatic PAD are managed well with medication and lifestyle
changes. Here, proper pharmacological control of cardiovascular risk factors
and initiation of an exercise program are known to reduce the risk of major
adverse cardiovascular events and to improve the walking distance. In more
severe cases, however, invasive treatments are needed to prevent progression of
symptoms, improve quality of life, or prevent eventual limb loss in patients
with the rest pain or ulcerations [4-9].

The most commonly diseased arterial segment in the peripheral circulation is
the femoropopliteal region [9]. Endovascular revascularization of de novo
femoropopliteal lesions <25 cm in length is widely accepted as the first-line
of treatment for claudicants who are failing medical management, and for
patients suffering rest pain or tissue loss [10]. The endovascular approach is
also indicated for patients with >25 cm long lesions
(occlusions/re-occlusions), that are unsuitable for a surgical bypass grafting
procedure (due to high surgical risk or no viable vein) [10]. Long-term patency
following treatment, however, is hard to achieve in this challenging segment.
This is due to the mobile nature and unique biomechanical properties of the
femoropopliteal region, making any implant subject to an extensive impact of
flexion torsion and compression forces. These contribute to the high early and
late restenosis rates after endovascular interventions [9-11].

In recent years, utilization of endovascular interventions in the treatment of
peripheral arterial disease in on the rise, with femoropopliteal interventions
accounting for >55% of cases [12]. Current therapeutic options include
bare-metal stents, drug-eluting stents, covered stents, conventional balloon
angioplasty, and drug-coated balloons [9], with or without the adjunctive
plaque debulking procedures. Despite this treatment versatility, the debate is
still ongoing concerning the best suitable treatment modality, meeting the
unique needs of this complex anatomical region. The most optimal
revascularization strategy quite often must be decided on an individual patient
basis [9]. In coming years, more dedicated clinical trials are warranted to
identify most optimal interventional avenues for various patient/lesion
subsets.

To this end, for instance, it has recently been demonstrated in randomized
controlled trial setting that some self-expanding bare metal stents (BMS) may
be significantly more durable than balloon angioplasty alone in treatment of
femoropopliteal lesions [13]. The long-term treatment effectiveness is,
nevertheless, still hard to achieve, especially in commonly encountered in the
real-world practice complex lesions (long occlusions, heavily calcified /ostial
lesions and popliteal disease extension). Fortunately, ever growing advances in
the field of endovascular interventions, including new (optimized) stent
designs and constant clinical practice improvements offer promise for the
future.

Nowadays, a plethora of BMS is used in the endovascular treatment of the
femoropopliteal segment. With its braided, self-expanding nitinol design Supera
Peripheral Stent system constitutes a unique class of technology. Its
biomimetic properties enable it to adapt to lower limb anatomy's natural
movement, while concomitantly optimizing luminal gain. Thereby, Supera stent
system achieves good treatment effectiveness in the highly dynamic
femoropopliteal segment [14].

Novel dual-layer micromesh RenzanTM Peripheral Stent System also features
braided nitinol design. Unlike Supera, however, RenzanTM stent in addition has
an internal micromesh, which should provide a better plaque coverage, and
thereby limit the risk of distal embolization. Pre-clinical bench tests
demonstrate that RenzanTM displays high radial resistive force (RRF) as
compared to its laser-cut stent counterparts and low chronic outward force
(COF), when compared to all its competitors (including Supera). The multiaxis
fatigue testing reveals a high fracture resistance for the RenzanTM stent ( 0
fractures after 10 million cycles (equal to 10 years in body)). RenzanTM also
shows high kink-resistance, conformability and flexibility, as well as good
pushability, not compromised by the RX delivery system (Data on file at
MicroVention). Finally, RenzanTM delivery system is easy to use and
re-positionable (up to 50% of deployment). Overall, these features should
ascertain the treatment durability, patient safety, stent placement accuracy
and operator satisfaction.

RenzanTM Peripheral Stent System should be a successful treatment modality for
the SFA and/or POP lesions, thanks to its unique design, allowing it to adapt
well to the dynamic forces of the femoropopliteal segment, without exerting an
excessive strain on the vessel wall. Based on the extensive clinical evidence
showing that femoropopliteal artery stenting is a viable endovascular treatment
option, we are confident that the RenzanTM stent, will become a valuable
addition to the current portfolio of the available treatment avenues for the
demanding femoropopliteal segment. With the present study, we aim to confirm
its safety and efficacy in this capacity.


1. Shu, J. and G. Santulli, Update on peripheral artery disease: Epidemiology
and evidence-based facts. Atherosclerosis, 2018. 275: p. 379-381.
2. Song, P., et al., Global, regional, and national prevalence and risk factors
for peripheral artery disease in 2015: an updated systematic review and
analysis. Lancet Glob Health, 2019. 7(8): p. e1020-e1030.
3. Fowkes, F.G., et al., Comparison of global estimates of prevalence and risk
factors for peripheral artery disease in 2000 and 2010: a systematic review and
analysis. Lancet, 2013. 382(9901): p. 1329-40.
4. Hirsch, A.T., et al., ACC/AHA 2005 guidelines for the management of patients
with peripheral arterial disease (lower extremity, renal, mesenteric, and
abdominal aortic): executive summary a collaborative report from the American
Association for Vascular Surgery/Society for Vascular Surgery, Society for
Cardiovascular Angiography and Interventions, Society for Vascular Medicine and
Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on
Practice Guidelines (Writing Committee to Develop Guidelines for the Management
of Patients With Peripheral Arterial Disease) endorsed by the American
Association of Cardiovascular and Pulmonary Rehabilitation; National Heart,
Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic
Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol,
2006. 47(6): p. 1239-312.
5. Fowkes, F.G., et al., Edinburgh Artery Study: prevalence of asymptomatic and
symptomatic peripheral arterial disease in the general population. Int J
Epidemiol, 1991. 20(2): p. 384-92.
6. Nehler, M.R., et al., Functional outcomes and quality of life in peripheral
arterial disease: current status. Vasc Med, 2003. 8(2): p. 115-26.
7. Shammas, N.W., Epidemiology, classification, and modifiable risk factors of
peripheral arterial disease. Vasc Health Risk Manag, 2007. 3(2): p. 229-34.
8. Burns, P., S. Gough, and A.W. Bradbury, Management of peripheral arterial
disease in primary care. BMJ, 2003. 326(7389): p. 584-8.
9. Diamantopoulos, A. and K. Katsanos, Treating femoropopliteal disease:
established and emerging technologies. Semin Intervent Radiol, 2014. 31(4): p.
345-52.
10. Aboyans, V., et al., Editor's Choice - 2017 ESC Guidelines on the Diagnosis
and Treatment of Peripheral Arterial Diseases, in collaboration with the
European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg, 2018.
55(3): p. 305-368.
11. Katsanos, K., et al., Bayesian network meta-analysis of nitinol stents,
covered stents, drug-eluting stents, and drug-coated balloons in the
femoropopliteal artery. J Vasc Surg, 2014. 59(4): p. 1123-1133 e8.
12. F, A., M.A.M.R.G., and Inc., Peripheral Vascular Devices - US - 2016 -
Market Analysis. Dec 2015: MedTech 360.
13. Iida, O., et al., Self-Expanding Nitinol Stent vs Percutaneous Transluminal
Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the
SM-01 Trial. J Endovasc Ther, 2019. 26(2): p. 158-167.
14. Bishu, K. and E.J. Armstrong, Supera self-expanding stents for endovascular
treatment of femoropopliteal disease: a review of the clinical evidence. Vasc
Health Risk Manag, 2015. 11: p. 387-95.

Primary objective: To confirm the safety and efficacy of the RenzanTM
Peripheral Stent System when used for treatment of superficial femoral (SFA)
and/or popliteal (POP) artery disease.

Secondary objective: Assessment of the primary patency of the artery evaluated
at 12 months, compared to clinical results coming from the cinical trials using
similar metallic scaffolds.

Prospective, multicenter, single arm study with up to 36 months follow-up.

Stent placement at the index procedure with the help of a catheter and
angiogram. Follow up to check on blood flow with Duplex Ultrasound is done on 1
month, 6 months, 1 year, 2 years, 3 years.

The potential risks associated of treatment with the Renzan* Peripheral Stent
System are in nature and in frequency expected to be similar to the risks
associated with implantation of any other braided nitinol dual stent.
The evaluations within the PRIZER study are the routine patient work-up
evaluation per the ESC guidelines or are non-invasive with a low burden to the
patient.