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Arterial Occlusive Diseases clinical trials

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NCT ID: NCT03668353 Recruiting - Clinical trials for Critical Limb Ischemia

Recombinant SeV-hFGF2/dF Injection for PAOD

Start date: September 5, 2018
Phase: Phase 1
Study type: Interventional

Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs. Although bypass surgery and angioplasty ( or interventional therapy ) are effective methods for vascular treatment in patients with PAD to revascularize, a significant proportion of patients with the arterial disease are not eligible for direct arterial surgery. Meanwhile, there are many patients who suffer from diffuse arterial disease or severe peripheral disease not suitable for interventional therapy. Stimulation of arteriogenesis( blood bypassing the occluded arteries through a large number of collateral vessels ) and angiogenesis ( generating new small blood vessels ) have become the focus of research. Our recombinant SeV-hFGF2/dF injection (R&D code BF30 ) uses the human basic fibroblast growth factor ( FGF2 ) gene to express the target protein FGF2 locally by intramuscular injection. The preparation can efficiently express FGF2 in infected cells and secrete it to the periphery and be fixed in the intercellular substance. Since FGF2 is in the upstream regulatory pathway of VEGF, HGF and other factors, it can regulate the coordinated expression of these cytokines related to the growth and function of new blood vessels, and finally, produce mature blood vessels. To evaluate the safety ( tolerance), pharmacokinetics (PK), biological activity, and immunogenicity of BF30 in patients with lower extremity arterial occlusive disease, and to explore clinical benefits. MAIN OBJECTIVE: To evaluate the safety ( tolerability ) of single-dose BF30 in patients with lower extremity arterial occlusive disease, and to provide evidence for the dose of subsequent clinical trials. Secondary objective: To explore the pharmacokinetics (PK), biological activity, the immunogenicity of BF30, and to initially explore clinical benefits.

NCT ID: NCT03638115 Recruiting - Clinical trials for Peripheral Artery Disease

The VaSecure BTK Study

Start date: October 30, 2018
Phase: N/A
Study type: Interventional

To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)

NCT ID: NCT03630055 Recruiting - Clinical trials for Radial Artery Occlusion

Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion

CAPITAL-RAPTOR
Start date: October 3, 2018
Phase: Phase 3
Study type: Interventional

Coronary angiography is performed to evaluate for obstructive coronary artery disease. This is commonly performed via the transfemoral or transradial approach with the latter increasing in frequency. One of the most common complications of transradial access is radial artery occlusion occurring in ~5% of patients which prohibits the use of the radial artery in the future. There is evidence to support the use of intraprocedural anticoagulation to mitigate the risk of radial artery occlusion however the role of post-procedural anticoagulation has not been previously evaluated. Rivaroxaban is a direct oral anticoagulant (DOAC) with a safety profile superior to that of vitamin K antagonists. Given the safety profile, ease of use, and feasibility of DOAC therapy, our study will endeavor to evaluate the use of rivaroxaban 15mg orally once daily for 7 days after transradial access and the impact this has on the rate of radial artery occlusion.

NCT ID: NCT03558243 Recruiting - Complication Clinical Trials

Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Intervention

PROTHECT
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates three hemostatic methods for prevention of radial artery occlusion. One third of patients will receive patent hemostasis, another third will receive patent hemostasis plus ulnar compression and the last third will receive the StatSeal hemostatic disc.

NCT ID: NCT03543345 Recruiting - Clinical trials for Right Coronary Artery Occlusion

Right Ventricular Function Change After PCI to Right Coronary Artery

Start date: June 1, 2018
Phase:
Study type: Observational

Proximal RCA occlusions were very often found among men with fatal pre-hospital MI; whereas left-sided coronary occlusions were significantly more frequent in hospital-admitted survivors of MI. Left-sided coronary occlusions may be associated with a more favorable pre-hospital phase of acute MI compared to proximal RCA occlusions. Proximal RCA occlusion increases the risk of arrhythmia and shock leading to increase the mortality. Sinus bradycardia and cardiogenic shock accounts for the majorities of the mortalities of RCA occlusion

NCT ID: NCT03313817 Recruiting - Clinical trials for Magnetic Resonance Imaging

Pre and Post-arterial Recanalization Imaging of Central Retinal Artery Occlusions (CRAO)

I-RECANAL
Start date: December 13, 2017
Phase:
Study type: Observational

Central retinal artery occlusions (CRAO) are the equivalent of an ischemic stroke at the retinal level. They share the same risk factors and common pathology. The diagnosis of a CRAO is clinically based on the sudden occurrence of a decrease in deep visual acuity with fundamentally signs of reactive ischemia. Small studies have highlighted the value of cerebral MRI (Magnetic Resonance Imaging) in CRAO with almost 25% of ischemic strokes found on diffusion sequences and the demonstration of a correlation between anomalies in diffusion sequence and the probability of a pathology with a high risk of recurrence (carotid stenosis or emboligenic cardiopathy). But there are usually few radiological signs that allow a direct positive diagnosis of CRAO, an etiologic diagnosis or a prognosis. This descriptive study will focus on CRAO at the diagnostic and post-treatment phases in the short and medium term, in order to (i) identify imaging etiologic signs of CRAO with specific sequences from a 3 Tesla MRI, (ii) identify positive diagnostic signs of CRAO with the same specific sequences, (iii) correlate these signs with the visual prognosis one month after the CRAO.

NCT ID: NCT03248323 Recruiting - Clinical trials for Arterial Occlusive Diseases

A Prospective Study: the Value of Using iFlow and PBV in the Endovascular Treatment of Infrapopliteal Arterial Occlusive Diseases

Start date: June 2016
Phase: N/A
Study type: Observational [Patient Registry]

Color coded blood flow and blood perfusion techniques are applied to the endovascular treatment of infrapopliteal arterial occlusion,to establish a method of quantitative evaluation of blood flow and tissue perfusion,to improve the level of calculation of condition and curative effect. So as to establish a new complete evaluation system of infrapopliteal arterial occlusive disease, to guide clinical further. At the same time establish a digital information platform for clinical, lay the foundation for the large research.

NCT ID: NCT02593994 Recruiting - Clinical trials for Coronary Artery Disease

IRIS-Onyx Cohort in the IRIS-DES Registry

IRIS-Onyx
Start date: October 2015
Phase:
Study type: Observational

The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.

NCT ID: NCT02122497 Recruiting - Clinical trials for Arterial Occlusive Diseases

The Use of Cardiovascular Biomarkers in Abdominal Aortic Surgery

BIAS
Start date: January 2011
Phase: N/A
Study type: Observational

The aim of the present study is the evaluation of cardiovascular biomarkers in patients with abdominal aortic aneurysms (AAA) or abdominal aortic occlusive disease AOD) undergoing open (OR) or endovascular aortic repair (EVAR) with regards to short- and long-term outcome. By blood collection and measurement of the serum biomarkers Copeptin, N-terminal- pro Brain Natriuretic Peptide (NT-proBNP), cardiac Troponin I (cTnI), high sensitive Troponin T (hs-cTnT) and C-reactive Protein (CRP) we expect an improvement of patients stratification by assessment of cardiac stress tolerance. Data gathered may help to simplify the decision whether an open or endovascular approach for abdominal aortic repair (OR and EVAR) should be performed. Study Hypothesis: The evaluation of the predictive value of cardiovascular biomarkers (Copeptin, NT-proBNP, hsTnT, cTnI, CRP) improve patient stratification and selection of surgical treatment.

NCT ID: NCT01945255 Recruiting - Clinical trials for Cardiovascular Disease

The Relationship Between Aortic Pulse Wave and Peripheral Artery Occlusion Disease in Hemodialysis Patients

Start date: March 2012
Phase: N/A
Study type: Observational

Cardiovascular disease (CVD) is the leading cause of mortality in patients with end-stage renal disease (ESRD), which means that it is important to find out risk factors of CVD in order to prevent or treat it. In recent years, there has been more and more recognition of a very high prevalence of CV calcification in the ESRD population. Many observational cohort studies have shown that CV calcification in these patients can predict mortality, CV mortality and morbidity. Electrolyte imbalance is easily found in the ESRD patients which may result in vessel calcification. Calcification leads to arterial stenosis and increasing arterial stiffness and then heart afterload, both contribute to the development of CVD. Besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic, immune-mediated vascular inflammation and cardiovascular disease. These factors are prevalent in ESRD patients, which would also cause arterial stiffness. Arterial stiffness and stenosis would increase the risk of CV events and mortality. Aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and constitutes a forceful marker and predictor of cardiovascular risk. At the same time, high prevalence of peripheral artery occlusion disease (PAOD) should also be found while arterial stiffness and stenosis, which would increase the condition of infection and gangrene. Thus, life safety and quality would be influenced severely and early detection might prevent future amputation. Uremic patients also have a higher risk for metabolic syndrome. Therefore, more studies to evaluate the condition of arterial stiffness and PAOD, especially in HD patients, are needed for future management and preventions of CV related morbidity and mortality.