Peripheral Arterial Disease Clinical Trial
Official title:
Outcomes of Endovascular Treatment of Superficial Femoral Artery In-stent Restenosis
Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic
atherosclerosis. Stenosis or occlusions in the superficial femoral artery (SFA) may result in
intermittent claudication or even critical ischemia, which may be treated by balloon
angioplasty with or without stenting .
Atherosclerotic disease in the femoropopliteal (FP) artery consists of perfusion to the legs
and feet. Percutaneous transluminal angioplasty (PTA) has been routinely used to manage FP
artery disease and is recommended as an alternative to surgical bypass. Recently, newer
endovascular approaches such as covered stent, drug-eluting balloon (DEB), drug-eluting stent
(DES), or catheter based atherectomy have been introduced as treatment options for FP artery
disease. Nevertheless, FP artery-in stent restenosis (ISR) is still a major challenge with
endovascular therapy .
Although the use of peripheral arterial stents brought about a dramatic improvement in
patients' clinical and procedural outcomes, the long-term outcome of stent implantation
remains significantly constrained by the risk of developing in-stent restenosis (ISR) over
time.
Advancements in endovascular stent technology have addressed limitations associated with
conventional percutaneous transluminal balloon angioplasty in patients with chronic
peripheral arterial disease (PAD) of the lower limbs, such as elastic recoil,residual
stenosis and flow-limiting dissection . However, a considerable proportion of patients with
PAD treated with stenting will require secondary interventions due to in-stent restenosis
(ISR), which is particularly common in long and complex lesions ISR refers to loss of luminal
volume from an ingrowth of cells, extracellular matrix, and thrombus within the cylinder of
the stented artery and 5-mm margins proximal and distal to the stent. ISR has been reported
to occur in 18-40% of patients undergoing stenting in the femoropopliteal segment within the
first year of treatment .
The treatment of ISR is one of the major challenges in endovascular therapy for PAD. The
treatment options for ISR include standard balloon angioplasty with or without repeat
stenting (using bare-metal stents, stent grafts or drug-eluting stents), drug-coated or
cutting balloon angioplasty, cryoplasty and directional or laser atherectomy .
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