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Vascular Diseases clinical trials

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NCT ID: NCT01569334 Active, not recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy

Start date: February 2011
Phase: N/A
Study type: Interventional

Heart transplantation is the best option for patients with end-stage heart failure. Cardiac allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of coronary artery disease (CAD) with similarities to atherosclerosis but also particular features of endothelial dysfunction associated to the alloimmune conflict and humoral responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method for late CAV diagnosis, but occurs lesions are established. Identification of reliable non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage thus remain a major challenge to optimize therapeutic management of post transplant morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16) and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA receptors), Natural Killer (NK) cells represent effector cells with unique potential to generate both humoral and innate immune injury of graft endothelium.

NCT ID: NCT01562041 Terminated - Clinical trials for Atherosclerotic Coronary Vascular Disease

Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease

Start date: March 9, 2012
Phase: Phase 2
Study type: Interventional

The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).

NCT ID: NCT01558908 Not yet recruiting - Clinical trials for Peripheral Vascular Diseases

Phase I/II Trial of Endometrial Regenerative Cells (ERC) in Patients With Critical Limb Ischemia

Start date: May 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a 15 patient clinical trial assessing the safety and feasibility of using Endometrial Regenerative Cells (ERC) in patients with critical limb ischemia (CLI) that are not eligible for surgical or catheter-based interventions. Three doses of ERC will be examined. The hypothesis is that ERC administration will be well-tolerated and possibly induce a therapeutic benefit.

NCT ID: NCT01548378 Completed - Clinical trials for Peripheral Vascular Disease

Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia

NL003CLI-II
Start date: March 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia

NCT ID: NCT01543555 Completed - Clinical trials for Myocardial Infarction

Lowering the Risk of Operative Complications Using Atorvastatin Loading Dose

LOAD
Start date: November 2012
Phase: Phase 3
Study type: Interventional

Patients submitted to noncardiac surgeries are at increased risk of serious cardiovascular complications. Statins have shown to lower cholesterol levels and reduce cardiovascular events in other scenarios. The objective of this study is to explore the effects of atorvastatin, as compared with placebo, on the 30-day risk of a composite of death, nonfatal Myocardial Injury after Noncardiac Surgery (MINS), or stroke among patients who undergo noncardiac surgery.

NCT ID: NCT01541774 Completed - Clinical trials for Peripheral Vascular Disease

Endovascular Atherectomy Safety and Effectiveness Study

EASE
Start date: August 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in the native peripheral arteries. The Phoenix Atherectomy™ System is intended for use in atherectomy of the peripheral vasculature. The intended peripheral vessels include the Superficial Femoral, Popliteal, and Infrapopliteal arteries. The system is not intended for use in the coronary, carotid, iliac or renal vasculature. The results of this study will be used to support a 510(k) submission to the Food and Drug Administration.

NCT ID: NCT01527344 Completed - Clinical trials for Cardiac Allograft Vasculopathy

Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography

CAV-OCT-IVUS
Start date: August 2011
Phase: N/A
Study type: Observational

Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. The broad objective of this research study is to advance our ability to diagnose as early as possible the presence of CAV and to non-invasively predict those patients at increased risk of CAV with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, Minnesota (MN) that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial function testing. The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function scores.

NCT ID: NCT01526811 Completed - Clinical trials for Cardiovascular Diseases

Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)

Start date: March 2012
Phase:
Study type: Observational

The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and rupture of the aneurysm on a long term, i.e. at 5 years, in a cohort of patients representative of the population treated under real-life conditions of use in France.

NCT ID: NCT01522495 Completed - Clinical trials for Peripheral Vascular Disease

Pilot Study to Determine Percent Tissue Perfusion and Cellular Viability Using SPY Imaging

Start date: April 2013
Phase: N/A
Study type: Interventional

Little is known about chronic wound microenvironments, especially in peripheral vascular disease (PVD) and diabetic patients. At the demarcation line, the percentage of viable cells and tissue is unclear. A means to determine cell viability, particularly discerning an apoptotic or necrotic cell pathway would indicate where the line of demarcation should be drawn. The information generated would better predict clinical outcome using SPY Imaging. Cellular studies are needed to successfully confirm a clear line of demarcation to eliminate surgeon subjectivity.

NCT ID: NCT01520311 Terminated - Clinical trials for Coronary Artery Disease

The eSVS® Mesh Post-Marketing Trial

Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonography Results and coronary angiography and major cardiovascular or cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.