Metformin Therapy in Non-diabetic AAA Patients
Abdominal Aortic AneurysmA prospective randomized, double blind, placebo-controlled, safety and efficacy study of metformin as add-on therapy in abdominal aortic aneurysm (AAA) OBJECTIVES Primary Objective To demonstrate treatment efficacy of metformin in AAA in comparison to placebo or active comparator, as measured by growth of the AAA maximum diameter at 12 months Secondary Objectives To asses inflammatory cytokines and parameters of neutrophil activation in AAA in response to metformin treatment by glucose insulin Interleukin-6 markers of neutrophil activation (MPO, elastase, NGAL)
The Branch-based Intraoperative Stent System in the Treatment of Stanford A Aortic Dissection(BROAD)...
Aortic DissectionAneurysm4 moreThe purpose of the study was to evaluate the safety and efficacy of a branched type intraoperative stent system for the treatment of Stanford type A aortic dissection
LTA-guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms
Intracranial AneurysmThe use of intracranial stents broadens the indications for endovascular treatment of intracranial aneurysms and improves the cure rate, but it also increases the risk of postoperative ischemic complications in patients. The current standard dual antiplatelet regimen is considered to be an important method to reduce thrombotic events. However, some patients are resistant to antiplatelet drugs and have a high risk of thrombotic events. In actual clinical work, the standards for platelet function testing are not standardized, and the antiplatelet drug adjustment program also lacks norms and consensus. This study carried out a multi-center, prospective cluster randomized controlled study to explore whether the standardized antiplatelet adjustment program guided by LTA detection can reduce the incidence of ischemic events after stent implantation in patients with intracranial unruptured aneurysms. Further determine and correct the curative effect of the standardized use of antiplatelet drugs in the treatment of intracranial aneurysm stents, and finally formulate a set of standardized antiplatelet regimens.
Reduction of Microembolism After the Intervention Surgery of Intracranial Aneurysms by Administration...
Intracranial AneurysmThe goal of this clinical trial is to investigate whether intravenous injection of tilofiban can reduce microembolism in patients with unruptured intracranial aneurysms after Stent-Assisted Coil Embolization.The main questions it aims to answer are: Is it safe to inject tirofiban intravenously during interventional treatment of intracranial aneurysms? What dose of tirofiban is safe and effective?
Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark...
Abdominal Aortic AneurysmsPeripheral Arterial Disease1 moreWell-documented health benefits may be achieved through prophylactic screening for cardiovascular disease. The advantages are fewer premature deaths and a reduction in the number of hospital admissions and amputations. Furthermore, hospitals will benefit from the derived reduction in the pressure on surgery and intensive care capacities at vascular surgery departments. It therefore seems extremely relevant to offer joint screening for abdominal aortic aneurysm, peripheral arterial disease and hypertension, even if the benefit and costs of such a measure are not currently known. Consequently, the primary objective of the study is to establish the effect and cost-efficiency of a joint circulation screening programme for 40,000 men aged 65-74 years in a randomised, clinically controlled study. The project manager will train six nurses to measure ABI and perform ultrasound scans of the aorta. The nurses form three teams which will each be equipped with a portable Doppler, blood pressure cuff and portable ultrasound scanner. Each team will operate from the hospitals in the Region. Civil registration number (in Danish: CPR), name and address information will be supplied by the Clinical Epidemiological Department (CED), which will also perform the randomisation in groups of approx. 1,000 to avoid too long a period from data extraction to invitation. Half of the randomised subjects will be invited to participate in a circulation examination focused on PAD, AAA and hypertension, while the other half will be controls Men with positive findings are informed and proper preventive actions is taken. Annual controls are offered, and AAA exceeding 5.5 cm in diameter is offered operation. The primary efficiency variables are death, cardiovascular death and AAA-death. The secondary efficiency variables are hospital services related to cardiovascular conditions and costs for such services in accordance with current DRG rates. The entire population, the controls as well as the screening group, will be monitored for a period of 10 years. Information concerning deaths, including date of death, is obtained from the Civil Registration System, information on visits to outpatient clinics and hospital admissions caused by cardiovascular conditions including amputations is obtained from the National Patient Registry. From the Danish Causes of Death Registry information on cause of death is collected. The information is classified with regards to cause; AAA or cardiovascular. The cardiovascular interventions are identified in the vascular surgery database (Karbasen). Major follow-up is performed at 3, 5 and 10 years. A steering and data validation group will be formed including the project manager and a representative from the Clinical Epidemiology Department. Furthermore, a vascular surgeon from each of the two affected departments in the region will participate. Total mortality, cardiovascular and AAA-related mortality and initial cardiovascular hospital service are compared for the two groups using Cox proportional hazards-regression analysis which facilitates description of the risk ratio. The cost-efficiency calculation will be adjusted for quality of life.
Application of Brachial Plexus Block in Patients Undergoing Cerebral Aneurysm Embolization Via Transradial...
Intracranial AneurysmTransradial Access(TRA)The aim of this study was to investigate the feasibility and mechanism of brachial plexus block(BPB) preconditioning in preventing upper limb vascular injury in patients undergoing interventional surgery for intracranial aneurysms via transradial access(TRA). A multicenter prospective clinical trial was designed. The study subjects were patients undergoing cerebral aneurysm embolization with TRA. BPB was given in the experimental group patients and no BPB in the control group. To evaluate the short and long-term protective effects of brachial plexus block on the upper limb blood vessels injury after operation, the upper limb vasospasm and hemodynamic changes during operation, upper limb vascular thrombosis and radial artery occlusion after operation were observed in the two groups.
Prophylactic vs Therapeutic Cerebrospinal Fluid Drain Placement During Endovascular Thoracoabdominal...
Spinal Cord IschemiaThis is a pilot study to be performed at the University of Alabama at Birmingham (UAB) and the University of Massachusetts to determine the feasibility and develop the processes for a future randomized controlled trial to evaluate the occurrence of spinal cord ischemia after endovascular thoracoabdominal aneurysm repair using prophylactic cerebrospinal fluid drains versus no pre-emptive drain. The research question to be addressed is as follows: In the setting of a comprehensive spinal cord ischemia prevention protocol, do prophylactic CSF drains decrease the rate of spinal cord ischemia (SCI) in patients undergoing endovascular thoracoabdominal aneurysm repair?
EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE...
Abdominal Aortic AneurysmEndoleakBeyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture. Secondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.
Clinical Study on the Prevention of Surgical Wound Complications for Aneurysmal Thoracic-abdominal...
Toraco Abdominal AneurysmThe patients will be randomized into two groups of 100 subjects each one. One arm will be randomized to treatment with a negative topical pressure system (Sistema Prevena ™); while the other arm ("control group") will be randomized to treatment with standard medication with sterile gauzes and a TNT patch or medicated patch as normal traditional medication in use. The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter the medication will be checked in the inpatient ward after 48 hours from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed. The medication will be renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery. For each evaluation the photograph of the medication must be taken (which will be deprived of all the identifying elements of the patient).
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing...
Coronary Artery DiseasePostoperative Complications4 moreThis study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.