View clinical trials related to Peripheral Vascular Diseases.
Filter by:This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II
Background: The treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR. Aim: The aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions. Methodology: This is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data. Endpoints: Primary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.
Peripheral arterial disease (PAD) is a disabling condition, with symptoms of muscle cramping or pain on exertion, which can substantially reduce quality of life. This study aims to see if AirGlove device improves participants circulation. This is phase 1 study and will be taken in 3 parts: Phase 1a will be undertaken in 10 healthy volunteers to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, quality of life and product usability following a single session. Phase 1b will be undertaken in 20 participants with intermittent claudication to assess the effects of the AirGlove device on lower limb arterial flow, tissue perfusion, quality of life and product usability both in a single session and following a 12-week trial of heat therapy. Phase 1c will be undertaken in 10 participants with critical limb ischaemia Rutherford stage 4 (rest pain). Lower limb arterial flow, tissue perfusion, pain scores, quality of life, and product usability will be assessed both in a single session and following a 2-12 week trial of heat therapy.
The purpose of this study is to evaluate the effectiveness of the Viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (DCB) with or without a bailout bare nitinol stent.
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion. Patients will be stratified for total occlusions.
Verify the effectiveness and safety of rapamycin coated balloon dilation catheter for the treatment of dialysis pathway stenosis or blockage lesions.
Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortality. Despite successful primary endovascular or surgical intervention, the corresponding symptoms of rest pain and/or non-healing ulceration in some patients may continue, and amputation in these patients is unavoidable. It is hypothesized that the functional integrity of the peripheral vascular microcirculation may be impaired in these patients. However, there are currently no techniques that allow direct quantification and visualization of the microcirculation due to the micro-vessel invisibility under angiography. In the coronary circulation, coronary flow reserve (CFR) indicates the capacity for maximal hyperemic blood flow and reveals impaired coronary microvascular function. Studies have shown the clinical significance of measuring microvascular resistance to predict myocardial salvage after myocardial infarction. The study will explore whether this concept of coronary flow reserve can be applied peripherally to patients with critical limb ischemia in order to determine whether measuring peripheral vascular flow reserve can determine the integrity of the microcirculation to predict limb salvage after endovascular intervention.
The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the anatomic severity of infrainguinal disease in CLTI patients. However, GLASS validation still needs to be completed, and the infrapopliteal (IP) target artery pathway (TAP) was easily influenced by the procedures. Thus the IP target artery could be selected either as the least diseased artery based on angiography or prospectively based on the angiosome concept. So the investigators aim to evaluate its correlation with clinical outcomes after revascularization.
This is a Phase IIa, multi-centre study conducted at 3 sites in Singapore (SGH and NUHS, KTPH). 70 patients with diabetes mellitus (DM) and peripheral arterial disease (PAD) will be randomised in a ratio 1:1 to receive normal saline control or MEDI6570 400mg by monthly subcutaneous injection for 9 months.
The study is a prospective, multicenter, randomized pilot study to evaluate the clinical outcome of the plaque atherectomy system followed by the UltrafreeTM drug coated balloon catheter versus the drug coated balloon in patients with chronic long femoropopliteal lesions.