This is a prospective, single-center, single-blind, two-arm, 1:1 randomized clinical trial. Patients who have undergone successful elective PCI will be screened with a lipid profile and eligible patients will be enrolled. Non-eligible patients will be enrolled in a registry. Randomization will be stratified by baseline LDL-C level and current statin therapy…
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to…
The primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI…
This study will develop a data registry of patients diagnosed with uveal melanoma (UM). This registry will provide data that will be used to support the development of novel therapies for this disease. In this study, we are focused on trying to better understand how uveal melanoma behaves and how it is treated at different medical centers around the country.
This study is trying to determine if using a Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides imaging support while directing the…
This is a prospective, single arm, three stage, multi-site, clinical investigation evaluating the safety and efficacy of the Carag Bioresorbable Septal Occluder (CBSO) to treat patients with clinically significant hole in the atrial septal defect compared to other commercially approved devices. The study is being done to determine the safety and efficacy of…
This prospective, multicenter, open-label, single arm, first-in human study will enroll up to 75 subjects aimed at examining the performance of the LAAC device for LAA closure.
You are invited to join voluntarily in a clinical research study to find out if the drug LXS196 alone or in combination with HDM201 is safe and has beneficial effects in people who have metastatic uveal melanoma. The purpose of this study is to determine the highest dose of LXS196 that can be given safely without unacceptable side effects as a single drug…
The purpose of this research study, is to learn whether an experimental device (called Evolut R) can help clear hardened blockage in coronary arteries (blood vessels that feed the heart muscle) in patients with a disease is called aortic stenosis.Subjects that choose to participate and are eligible will have their interventional cardiologist use this device…
This research study is being done to see if the study drug, IMCgp100, works and is safe as treatment for subjects with uveal melanoma who also test positive for HLA-A*0201. In this study IMCgp100 will be compared to three standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug), or pembrolizumab (an immunotherapy drug).…
The purpose of this study is to see if a new medication called ticagrelor given twice daily ismore effective than aspirin alone in preventing the occurrence of heart attack, stroke and/ordeath due to cardiovascular events in patients who have type 2 diabetes. Ticagrelor is anantiplatelet therapy (stop platelets from clumping together) and is approved for…
The purpose of this study is to find out what effects, good and/or bad, intermittent dosing of the medication Selumetinib will have on you and your uveal melanoma. Selumetinib is a medication that blocks (or turns off) MEK, a protein activated in some uveal melanoma cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop your cancer from growing.
The Saranas Early Bird Bleed The Saranas study uses a device is called the Early Bird Bleed Monitoring System (EBBMS) and it is intended to provide physicians with an early indication of a potential internal bleeding complication due to vessel injury that may occur during the procedure before any symptoms present.
The purpose of this study is to survey patients who have undergone a percutaneous coronary intervention (PCI) at Columbia University Medical Center in which the physician used a stent called the Promus Premier stent. Patients will be asked to do a brief 15-30 minute survey regarding their health since the PCI and stent implantation.
This is a Phase I study of a weekly intra-patient escalation dose regimen with IMCgp100 in patients with metastatic uveal melanoma (mUM). To help decide whether or not patients can take part in a research study looking at a new form of treatment for advanced uveal melanoma, their blood need to first be tested to determine their Human Leukocyte Antigen (HLA…
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
The purpose of this study is to evaluate the Biosensors BioFreedom Biolimus A9 Drug Coated Coronary Stent on people with coronary artery disease (blockages in the heart arteries) to determine if it is safe and effective.
The purpose of the treatment part of the study is to find out what effects drug crizotinib has, good and/or bad on people with "high risk" uveal melanoma after surgery or radiation for the eye. It is thought that giving crizotinib to patients with "high risk" uveal melanoma can lower the chance the cancer will come back. Uveal melanoma…
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured…
The purpose of this study is evaluate the benefits and safety of using the combination of drugs, AEB071 and BYL719 to treat patients with an advanced form of uveal melanoma. The study will have two parts. The first part twill test different dose levels of each drug.Once the highest safe dose level is found, another group of patients will be treated at that…
The purpose of this research is to find out whether it is safe to shorten the length of time that people at high risk for bleeding take blood thinners after being treated with a coronary stent.
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
This study is for patients with Coronary Artery Disease (CAD) and require a stent placement. The purpose of this clinical research study is to assess the safety and effectiveness of the Orsiro stent or a non-investigational Xience stent. The Orsiro stent is investigational, which means it is not yet approved by the FDA and can only be used in research…
A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are…