157 Clinical Trials for Various Conditions
To demonstrate that the Insight Pro Device is safe and effective for use in detecting lymphatic and venous disorders.
To ascertain the potential symptom improvement assessed by Cardiopulmonary Exercise Testing (CPET) in subjects with heart failure with preserved ejection fraction (HFpEF) and nonthrombotic iliofemoral venous lesions and/or iliocaval obstruction defined by MR or CT venography AND CEAP Clinical Category ≥3 prior to venous stenting.
The purpose of this research study is to assess the efficacy of custom-manufactured compression hosiery (also known as compression stockings) compared to similar off-the-rack (OTR) compression stockings.
The primary objective of this study is to compare two treatment strategies for symptomatic venous stasis disease with and without venous ulcer. These treatments are compression therapy alone vs. sclerotherapy of refluxing perforating veins with compression.
The etiologies of varicose veins and the progression to more serious forms of chronic venous disease and identification of appropriate diagnostic tests to better aid patient management by identifying individuals who may benefit from more aggressive treatment and/ or prophylactic measures.
Objectives: To quantify the clinical improvement and quality of life between patients wearing compression stockings versus anti-embolism stockings in patients with varicose veins and limb edema.
Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treated disorders shat harm the veins of the legs and at worst, cause skin inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVDs and that the intervention will become a standard of care for CVDs. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.
This research project is investigating the relationship between body weight and function of the leg veins using a special non-invasive technique known as venous plethysmography.
Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost anywhere in the body, but is most common in the arms and legs. This study will examine people who participated in a previous venous disease study to evaluate changes in leg veins and venous disease status over a period of 11 years.
Venous thrombosis is the development of a blood clot in a vein. Post-thrombotic syndrome (PTS) is a painful condition that can develop following a venous thrombosis in one of the deep veins of the leg. While PTS is mainly thought to occur because of damage to the vein, other factors may be responsible for the development of this condition. This study will analyze genetic and biologic samples from participants of a previous study to examine other possible causes of venous diseases and PTS.
Single arm, observational, multi-center, consecutively enrolling, post-market surveillance study. Treating patients in need of central venous access who have upper body venous occlusions or other conditions that preclude central venous access by conventional methods, and who meet the requirements described in the device labeling.
This is a prospective, multi-center, single arm, non-randomized study to define safety and efficacy of the Veniti Vici™ Venous Stent System in relation to pre-defined Objective Performance goals. A maximum of 200 patients at up to 45 centers worldwide will be enrolled. Thirty (30) feasibility patients will be enrolled at approximately 7-10 centers and 170 pivotal patients will be enrolled at approximately 45 centers worldwide. The follow-up period is 36 months.
Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy "sham" wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.
Randomized Controlled Trial to determine if the outcomes of sclerotherapy of the ulcer bed alone differ from a combination of ablation and sclerotherapy injections.
This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic iliofemoral venous obstruction.
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.
The BARD® Venovo™ Venous Stent Study is a non-randomized clinical study intended to collect confirmatory evidence of the safety and effectiveness of the Venous Stent for the treatment of iliofemoral occlusive disease.
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
The purpose of the study is to quantitatively characterize the flow in the pelvic venous structures using 2D and 4D flow MRI with the objective of establishing physiologic and pathologic parameters for downstream computational fluid dynamics analysis. Arm 1: To establish the baseline flow characteristics of the iliac veins in patients with no imaging evidence of iliac venous disease. Arm 2: To assess the flow characteristics of the iliac veins in patients with left iliac vein compression syndrome (a.k.a. May-Thurner syndrome). Arm 3: To assess the flow characteristics of the iliac veins in patients status post iliac stent placement.
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
The Sinai Vein Stent Registry aims to establish and maintain a registry of patients who have undergone a vein stent placement procedure at The Mount Sinai Medical Center. The purpose of this study is to monitor and evaluate the long-term outcomes of venous stents placed to treat venous outflow obstruction. Outcome variables that will be assessed are: patency rate, reintervention rate, occurrence of any complications, clinical improvement, and quality of life. Venous outflow obstruction is defined as a stenosis and/or occlusion seen primarily in the ilio-femoral vein and inferior vena cava, and infrequently in the subclavian vein, brachiocephalic vein, or superior vena cava. While vein stent placement procedures are currently being performed in the United States, using stents which are commercially available and FDA-approved for use in arterial interventions, at this time there are no stents that are FDA-approved for use in veins. The placement of stents in veins holds tremendous promise as a treatment for venous outflow obstruction, but review of current literature has showed a paucity of published data on the long-term outcomes of this treatment. The study is composed of two arms, a retrospective arm and a prospective arm. Any patient over the age of 18 who has undergone or is scheduled to undergo a vein stent placement procedure is eligible for this study. A HIPAA waiver and waiver of informed consent are being requested for the retrospective arm for patients who have undergone a vein stent placement procedure from January 1st 2012 to date of study onset, as it is not possible to contact all patients in the retrospective arm (i.e., lost to follow-up, no longer follows-up with a study physician). This study is only interested in the collection and analysis of data; the clinical care and outcomes of research subjects will not be affected by their participation in this study. An IDE application has been submitted to the FDA for use of the Wallstent™ (manufactured by Boston Scientific, Inc.) in veins as treatment for venous outflow obstruction. The primary stents being used as treatment for venous outflow obstruction at Mount Sinai is the Wallstent™, mainly due to the fact that only Wallstents™ are available in the appropriate sizes to be used in veins. In rare occasions or exceptional circumstances, a smaller self-expanding nitinol stent may be used. Due to the extremely rare frequency of stents other than Wallstents™ being used and the impracticality (if not impossibility) of obtaining IDEs for all other stents, the investigators believe it is appropriate to exclude usage of these stents from the study data. To confirm, the purpose of this study is to monitor and evaluate long-term outcomes of the venous stents/the vein stent placement procedure, not specifically the Wallstent™ itself.
A randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative Protein-Calorie Restriction (PCR) diet in comparison to a normal ad libitum diet for 4 days before elective vascular surgery involving a major operation. After a pilot study exploring the safety and feasibility of the PCR diet conducted inpatient before carotid endarterectomy titled Short-Term Endogenous Hydrogen Sulfide Upregulation, and a follow-up study titled Dietary Restriction in Vascular Surgery, the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures. This study will further elucidate not only the practicality of pre-operative short term dietary restriction, but also provide early data to inform biologic mechanisms and to inform future efficacy trails.
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal. The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low. The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.
A prospective, non blinded, single arm, multicenter study designed to assess the safety and effectiveness of the bioprosthetic, VenoValve, which is surgically implanted into the deep venous system for treatment of patients with deep venous valvular insufficiency ( C4b-C6 patients).
Patients with end stage renal disease (ESRD) are at significantly increased risk of thrombosis and bleeding relative to those with normal renal function which makes anticoagulation particularly challenging. Further, ESRD patients undergoing initiation of anticoagulation for acute VTE are often kept in the hospital for heparin "bridging" which may lead to a protracted length-of-stay (LOS) and may place patients at risk for hospital-associated complications. The advent of direct oral anticoagulants (DOACs) has offered physicians choices in the management of venous thromboembolism (VTE). However, evidence suggests that rivaroxaban and dabigatran are associated with a higher risk of bleeding in ESRD patients. In contrast, research suggests that apixaban may be safer in patients with ESRD, and recent evidence suggests lower bleeding rates in ESRD patients treated for atrial fibrillation with apixaban compared to those treated with warfarin. However, to date, no large national cohort studies have examined the safety, effectiveness, and healthcare utilization of apixaban in patients with ESRD who have acute VTE. The investigators propose to use the Standard Analytic Files from the United States Renal Data System (USRDS) for years 2014 through 2018 to evaluate the safety, effectiveness, and healthcare utilization of ESRD patients initiated on apixaban compared to those initiated on warfarin (following heparin) to treat acute VTE.
The VeClose Five Year Follow-up Extension Study will seek to gain additional follow-up data from the patients enrolled in the VeClose study (NCT01807585).
VTE associated harm is underappreciated among hospitalized patients and may be associated with missed doses of VTE prophylaxis medications. In order to ensure best practices, and administer a defect-free VTE prevention nurses must understand and educate patients on the importance of the VTE prophylaxis. We propose to conduct a randomized trial comparing the effect of a validated, real-time patient education bundle (PEB), to a program of nurse feedback and coaching (NFC) provided by nurse leaders.
Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more pronounced platelet inhibition, and may substantially improve graft patency following CABG compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on saphenous vein graft patency following CABG. In this context, the investigators seek to compare vein graft patency between patients randomized to receive aspirin therapy, the current standard of care, or ticagrelor treatment, starting in the early postoperative period, and continuing for 2 years after CABG.