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 .
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
| Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
| Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
| Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
| Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
| Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
| Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
| Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
| Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
| Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
| Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
| Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
| Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
| Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
| Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
| Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
| Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
| Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
| Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
| Completed |
NCT02384980 -
Saving Life and Limb: FES for the Elderly With PAD
|
Phase 1 |