SOLARIS Endoprosthesis in Iliac Occlusive Disease
Peripheral Arterial DiseaseFifty patients will be treated with Solaris Endoprosthesis and followed up to 2 years with Walking Impairment Questionnaire and Doppler Ultrasound evaluation in 30 days, 6 months and 12 months.
Aortoiliac Stenosis in Kidney Transplantation
Aorto-Iliac Arterial StenosisPeripheral Arterial Disease1 moreThe impact of aortoiliac stenosis on kidney transplant patients remains unclear. This study aims to investigate the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis.
PMCF Study for Peripheral Arteries Above the Knee (ATK)
Peripheral Arterial DiseaseFemoropopliteal Stenosis2 moreThe rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
Peripheral Arterial DiseaseThis study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease...
Peripheral Arterial DiseaseTreatment with paclitaxel-based endovascular devices (PED) has become a common treatment option for patients with peripheral artery disease (PAD) involving the femoral-popliteal artery. However, an aggregate level meta-analysis identified an association between the use of PED and increased all-cause mortality at both two and five-year follow-up intervals, though there are significant limitations of these analyses. Exploration of real-world data has been suggested as a means to further investigate the safety of PED. The current study explores the association of PED and mortality in real-world data using U.S. commercial claims from the FAIR Health data warehouse.
A Study to Collect Data on the Treatment Pattern of Xarelto + Acetylsalicylic Acid in the Routine...
Coronary Artery DiseasePeripheral Artery DiseaseThe study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. The study will help to collect data for prevention cardiovascular death, myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. The study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.
DISRUPT PAD III Observational Study
Peripheral Arterial DiseaseThe Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions. Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.
PAD Awareness Study
Peripheral Arterial DiseasePeripheral arterial disease (PAD) is one of the most common cardiovascular diseases in developed countries [1] and is an emerging problem in developing countries [2, 3]. The prevalence of PAD in European population studies ranged from 3.6 to 9.2 % and 10-20 % in those aged over 70 years [4]. In a recent meta-analysis, the prevalence of PAD in China increased gradually by age until mid-60s, after which the increase accelerated. In the early stages, PAD is mostly silent. With the progression of disease, it may manifest as intermittent claudication, pain at rest, non-healing ulcer and gangrene resulting in lower-extremity amputation [5]. PAD is a major cause of disability, loss of employment, and lifestyle changes, and is a marker for systemic atherosclerotic diseases. Patients with symptomatic PAD have at least a 30% risk of death within 5 years rising to almost 50% within 10 years, resulting primarily from myocardial infarction or stroke [4]. Despite the major health risks associated with PAD, it is generally not recognized by clinicians or the general public in comparison with other cardiovascular diseases. However, asymptomatic individuals also have higher risk of adverse cardiovascular events similar to those with symptomatic PAD [6]. Many studies have shown that public awareness of PAD is much lower than that of other diseases. It has been reported that awareness of PAD ranged from 20 to 36 %, whereas awareness of other common diseases was more than 60 % in the same population [6-9]. Awareness is important for patients and physicians, and the need for public awareness programs has been highlighted [10, 11]. There is paucity of published literature on public awareness of PAD in Asian countries. It is difficult to reduce the morbidity and mortality of untreated PAD without adequate public awareness of PAD and its risk factors and consequences [7]. Insights into public awareness of PAD will help in developing strategies for behavioral change communication and health promotion. In this study we aimed to assess awareness of PAD among adults in Hong Kong. The survey is designed to measure knowledge of factors that increase the risk for PAD and the clinical risk consequences of having PAD. These data will provide useful information to guide future local public cardiovascular educational efforts.
EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs
Peripheral Arterial DiseaseCarotid Stenosis1 moreThe purpose of this study is to determine the prevalence and risk factors, at the time of the diagnosis of PAD, for asymptomatic carotid stenosis and abdominal aortic aneurysm.
Improving Intermediate Risk Management. MARK Study
Myocardial InfarctionAngina Pectoris2 moreCardiovascular risk functions fail to identify more than 50% of patients who develop cardiovascular disease. This is especially evident in the intermediate-risk patients in which clinical management becomes difficult. The purpose of this study is to analyze if ankle-brachial index (ABI), measures of arterial stiffness, postprandial glucose, glycosylated hemoglobin, self-measured blood pressure and presence of comorbidity are independently associated to incidence of vascular events and whether they can improve the predictive capacity of current risk equations in the intermediate-risk population.