Study on the Thrombolytic Effect of Platelet Membrane Coated Recombinant Staphylokinase on Human...
Arterial ThrombosisRecombinant staphylokinase (r-SAK) is a third-generation thrombolytic agent produced by genetic engineering technology in 1985, which has better thrombolytic effect than streptokinase (SK) and urokinase (UK). It has similar biological properties to natural SAK, is highly selective to fibrin, does not activate systemic fibrinolysis, and can dissolve clots in a short period of time without significantly increasing the risk of bleeding, especially for platelet-rich arterial clots. Previous studies have shown that the thrombolytic revascularization rate of r-SAK is significantly better than that of r-SK and UK at the same dose in the rabbit model of acute femoral artery occlusive thrombosis. The revascularization rate of coronary artery at 90 minutes after thrombolysis was significantly higher with r-SAK than r-tPA. The combination of thrombolytic drugs and nanocarriers may provide a new solution for the existing thrombolytic therapy. Inspired by the natural affinity of platelets (PLT) in hemostasis and pathological thrombosis, we have developed a thrombus targeting nanocarrier, which is a platelet membrane cloaked r-SAK(PLT-SAK)and compare the thrombolytic effect of PLT-SAK with different doses of free r-SAK on human arterial thrombus, aiming to further improve the thrombolytic effectiveness of r-SAK.
Vector Velocity Imaging in AAA Patients
Abdominal AneurysmThrombusThe goal of this observational study is to perform an in vivo feasibility study using real time (3D) ultrasound based vector flow imaging in 10 AAA patients (5 with intraluminal thrombus and 5 without intraluminal thrombus). Furthermore, the investigators will investigate the added value of contrast microbubbles in these high framerate, plane wave ultrasound measurements. Included patients will undergo ultrasound scanning of their AAA, using multiple ultrasound sequences. Sequences will be tested with and without the addition of ultrasound contrast microbubbles.
Ongoing Registry of Deep Venous Reconstructions
Venous ThrombosisOngoing registration of deep venous obstructive disease patients treated by means of percutaneous transluminal angioplasty (PTA) and stenting with or without endophlebectomy (surgical desobstruction, also termed endovenectomy) of the common femoral vein and/or arteriovenous fistula creation.
Mesoglycan (Prisma®) Versus Placebo in Secondary Prevention of the Superficial Venous Thrombosis...
Superficial Venous Thrombosis of LegSecondary PreventionThe objective of the study is to demonstrate the superiority of the mesoglycan (Prisma®), compared to placebo, in reducing the incidence of thromboembolic complications (relapse / extension of superficial venous thrombosis (SVT), deep venous thrombosis (DVT), pulmonary embolism (PE)) in patients who have completed the cycle of therapy of the acute phase after superficial vein thrombosis.
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Hematologic DisorderBleeding Disorder7 moreIn parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US.
Primary Care-Hospital Embedding: a Prospective, Multicentric, Observational Study
Heart FailureChronic Obstructive Pulmonary Disease6 moreThis is a multicentric, prospective, observational study with two cohorts and adjunctive procedure. It aims at collecting and analyzing data about the function of an innovative hospital-territory integration health service for the management of patients with intermediate urgency, or emergency department "white codes." This service, activated in the participating centers, will be provided in two alternative modalities, one so-called "dual specialty" (cardiology and diabetes specialist outpatient clinic) and a second one more focused on the figure of the specialist in Internal Medicine. The investigators will monitor the population treated in these centers (presenting complaint, medical history, clinical-radiological data, performed therapies and overall health path) and the degree of satisfaction of the General Practitioners who sent their patients there and the degree of satisfaction of the patients themselves. The data collected will also be used to evaluate the effectiveness of the outpatient clinics in terms of reducing improper admissions to the Emergency Departments and hospitalizations. The two modes of service delivery will be compared. This is an 18-month study, sponsored by our Scientific Directorate and carried out on a nonprofit basis. The study will enroll 246 patients and 30 healthy volunteer General Practitioners. The clinical trial will be conducted in accordance with Good Clinical Practice standards.
SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease...
Coronary DiseaseCoronary Artery Disease10 moreThe purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.
Cohort of Patients With Left Ventricular Thrombus: Management and Outcomes in the Direct Oral Anticoagulants...
Thrombus of Left VentricleThe investigators' primary objective is to assess whether a difference in the occurrence of bleeding events exist between patients with LVT treated with DOACs as compared to those treated with VKAs.
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF
Atrial FibrillationLeft Atrial Appendage Thrombosis1 moreThe primary objective is to demonstrate the safety and efficacy of the implantation of the LAmbre PlusTM device in patients with large or irregularly shaped appendages with non-valvular atrial fibrillation who are at increased risk for stroke and systemic embolism compared to oral anticoagulation (OAC).
Onabotulinum Toxin A (Botox) for the Treatment of Persistent Post-Stroke and Vascular Headache
Stroke (CVA) or TIAHeadache8 morePost stroke headache occurs in approximately 10-23% of all stroke patients. Its onset is shortly after experiencing a stroke, or stroke like event, and persists for at least three months. These headaches have features which resemble migraine or occur in people who have a previous history of migraine that was once infrequent. Botox is a treatment that is currently approved for the treatment of chronic migraine, that is migraine headaches occurring for at least 15 days a month for at least 3 months. Given the clinical similarity in character and frequency of post stroke headache and migraine, and the fact that stroke affects structures like the blood vessels in the brain that are also affected in migraine, this study is to investigate the possible role that Botox would have in the treatment of Post-Stroke Headache.