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Vascular Diseases clinical trials

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NCT ID: NCT00721006 Completed - Clinical trials for Peripheral Artery Disease

Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia

MESENDO
Start date: June 2008
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product. Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores. LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful. In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg. The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg. Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures. Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.

NCT ID: NCT00715416 Completed - Clinical trials for Intermittent Claudication

PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

Start date: June 2004
Phase: Phase 4
Study type: Interventional

The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.

NCT ID: NCT00703794 Completed - Vascular Diseases Clinical Trials

Researching AXIUM Coiling Experience and Recanalization (RACER)

RACER
Start date: June 2008
Phase:
Study type: Observational [Patient Registry]

The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System. This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.

NCT ID: NCT00703261 Completed - Clinical trials for Atherosclerotic Vascular Disease

Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque (MK-0000-081 AM3)(COMPLETED)

Start date: August 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the utility of 18Fluorine Fluorodeoxyglucose Positron Emission Tomography (18FDG-PET) as a tool to quantify atherosclerotic plaque.

NCT ID: NCT00693940 Completed - Clinical trials for Cardiovascular Diseases

Effectiveness of Group Walking Sessions for Increasing Activity in People With Peripheral Arterial Disease (The Group Oriented Arterial Leg Study [GOALS])

Start date: June 2008
Phase: Phase 3
Study type: Interventional

Lower extremity peripheral arterial disease (PAD) is a disease in which fatty build-up, or plaque, accumulates in the arteries of the legs. People with lower extremity PAD often experience leg pain while walking, which is caused by reduced blood flow to the legs. Regular walking has significant benefits for people with blood flow problems in their legs, but previous studies have shown that most men and women with PAD do not walk for exercise on a regular basis. A group home-based walking program may help people with PAD to walk more often and improve their lower extremity functioning. This study will evaluate the effectiveness of a home-based group mediated cognitive behavioral (GMCB) exercise program in helping people with lower extremity PAD to increase their walking frequency and improve their lower leg functioning.

NCT ID: NCT00693758 Completed - Myocardial Ischemia Clinical Trials

Assessment of Oxygen Changes in the Heart With Cardio-vascular Magnetic Resonance Imaging

Start date: January 2006
Phase: Phase 0
Study type: Interventional

The ability of a new SSFP-based BOLD MRI sequence to assess myocardial oxygenation changes in response to coronary flow changes induced by adenosine and increased CO2-partial pressure will be examined in healthy volunteers and patients with suspected coronary artery disease. Also the susceptibility of a new SSFP-based BOLD sensitive MRI sequence to changes in arterial oxygenation will be examined. This will help understand the physiologic basis of oxygen sensitive imaging of the heart.

NCT ID: NCT00677404 Completed - Ischemia Clinical Trials

Autologous Transplantation of Bone Marrow Mononuclear Cell (BM-MNC) With and Without Granulocyte-Colony Stimulation Factor (G-CSF) for Treatment of Chronic Lower Limb Ischemic Patients

Start date: January 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of mononuclear cells with and without G-CSF in patients with chronic lower limb ischemia.

NCT ID: NCT00674323 Completed - Clinical trials for Polypoidal Choroidal Vasculopathy

Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy

PCV
Start date: April 2008
Phase: Phase 4
Study type: Interventional

This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy.

NCT ID: NCT00670540 Completed - Pulmonary Embolism Clinical Trials

Epidemiology of Thromboembolism Disease: A Cohort Study

OPTIMEV
Start date: November 2004
Phase: N/A
Study type: Observational

The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied 1. do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ? 2. Is it necessary to obtain a detailed history of thromboembolic disease ? 3. Do older patients have particular risk factors ? 4. Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ? 5. Do predictive clinical scores have the same performance for both in and outpatients ? 6. Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ? 7. The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

NCT ID: NCT00667381 Completed - Clinical trials for Peripheral Vascular Disease

Femoral Arterial Access With Ultrasound Trial

FAUST
Start date: April 2008
Phase: N/A
Study type: Interventional

This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.