Superficial Femoral Artery Disease Clinical Trial
Official title:
Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
The aim of this study is to evaluate whether primary stenting with self expanding stent in patients with peripheral arterial disease suffering from stable claudication due to superficial femoral artery disease results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using established surveys. Patients will be followed up 24 months after treatment. Planned recruitment and randomization of 100 patients was completed June 2015.
Occlusive disease of the femoro-popliteal arteries is associated with symptoms ranging from
pain in the calf on exertion to pain at rest and ultimately ulceration and gangrene.
Treatment options include a) conservative measures, with attention to medical risk factors,
smoking cessation and exercise programmes, b) minimally invasive treatments such as
angioplasty and c) surgical procedures such as femoro-popliteal bypass grafts.
Percutaneous transluminal angioplasty (PTA) has been widely used in the treatment of
femoro-popliteal stenosis and occlusion for many years. However, the medium and long-term
results have always been suboptimal due to a high rate of restenosis.
With restenosis rates of 70 % with PTA alone in long SFA lesions. Factors which contribute to
poor results include the presence of occlusion rather than stenosis, the length of the lesion
and the severity of run-off vessel disease.(1)
Stents are expandable metal mesh tubes which are widely used in the treatment of arterial
disease in the coronary, renal and iliac arteries, where they have been shown to have
superior patency to balloon angioplasty alone.
In the treatment of SFA lesions several early studies have investigated the patency of
balloon expandable stents. These are stents with low flexibility and high risk of deformation
in SFA. Medium and long-term results are not better than with PTA alone.(2)
Self expanding nitinol stents are stents generally with high flexibility and moderate to high
radial force. Initial studies have shown promising results in the SFA.(3)
Early prospective randomised studies , the Sirocco I and II study show as low as 7 %
restenosis rate at 6 months and 18% at 12 months self expanding nitinol stent.(4, 5) Later
studies have focused on the issue of the correlation of stent fractures and low patency.
These have shown that higher restenosis rates correlated to the length of the stented
segment, number of stents and stent brand (6)
Up to now the most frequent use of stents in the SFA is "bailout" stenting. Investigated in a
prospective randomised trial on patients with severe claudication or critical ischemia with
long lesions (130 +- 60 mm) primary stenting in the SFA is showing superior results to PTA
with bailout stenting on restenosis rate, ABI and walking distance.(7) There are for the
moment two more trials investigating the results of direct stenting.
The FAST trial investigated claudicants with short lesions (4,5 cm); the stent arm used
Luminexx stents versus PTA alone with no significant in difference in patency between both
treatment arms after 12 months follow up.(8) The Resilient trial investigated patients with
claudication and critical limb ischemia with 6,5 cm long lesions. The results are not
published, but positive "pre hand" information has already come out. (9)
The most accepted treatment in claudicants is conservative best medical treatment with or
without supervised walking training.(10) There is a trend to stent treatment in certain
situations.
There are to the best of our knowledge no studies comparing direct stenting with conservative
treatment in claudicants.
The aim of this study is to evaluate whether primary stenting with nitinol self expanding
stent in patients suffering from stable claudication (Fontaine IIa and IIb) due to
superficial femoral artery disease, results in improved patient outcomes, compared to
conservative treatment alone as measured by improvement in Quality of Life scores at 12
months after treatment using SF-36 and EuroQol EQ-5D surveys. Patients will be followed up 24
months after treatment.
A secondary objective is to study the impact of primary stenting versus conservative
treatment on ABI and Walking Distance development during the 24 month follow up period. In
addition, cost-parameters will be collected in each arm to allow for basic cost-effectiveness
comparisons after 24 months.
12 month follow-up data have been published in Eur J Vasc Endovasc Surg 2017;53:686-694. All
24 month follow-up data have been collected, and a manuscript is in preparation.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04546477 -
Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease
|
N/A | |
| Completed |
NCT00739102 -
S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease
|
N/A |