This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Design: A prospective, randomized, controlled clinical trial to study the effectiveness of applying guided femoral artery access in the cardiac catheterization lab and its effect on the usage of FDA approved femoral artery closure devices. This trial will randomize patients between fluoroscopy guided femoral artery access or femoral artery access using the usual anatomic landmarks and will then study the difference in the ability to use closure devices on the access site. Purpose: To establish the safety and efficacy of using fluoroscopic assistance to allow access of the common femoral artery rather than its branches and thus increase the ability to use the access site. Enrollment: An approximate enrollment of up to 1000 patients (all patients randomized) who will be undergoing cardiac catheterization and who meet all the eligibility criteria at OUMC and VAMC in Oklahoma City. Duration: The study will be conducted over approximately one year. Primary Endpoint: Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm. Secondary Endpoints: 1. Compare the incidence of known major side effects of femoral artery puncture between the two methods of access. 2. Compare the time and number of attempts needed to obtain arterial access between the two groups of patients. 3. Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists. 4. Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows. Analytical Subset: Intention-to-treat sample
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