SFAOptimal Stent Selection for the Femoropopliteal Artery
Colección de datos
Recopilados desde hoy en adelante - ProspectivoOtro
Uso de métodos específicos que no están cubiertos por los modelos estándar para abordar preguntas de investigación únicas.Resumen
Fecha de inicio: 2 de septiembre de 2014
Fecha en la que se inscribió al primer participante.This is an observational study of PAD patients that have already received SFA and PA stents as part of their standard of care. The purpose of this study is to determine the effects of Peripheral Artery Disease (PAD) stenting on the femoropopliteal artery. This will be achieved through the following Specific Aims: Aim 1. Evaluate pre-operative lower extremity CTAs of patients with PAD and determine the baseline arterial geometry and lesion characteristics. Aim 2. Evaluate the results of intraoperative angiography and blood pressure measurements proximal and distal to the stent. Aim 3. After stenting perform post-operative lower extremity CTA and assess the amount of in-stent restenosis and changes to the arterial geometry. We propose to build mathematical models of human femoropopliteal arteries repaired with several of the most commonly used PAD stents and assess the mechanical stress associated with limb flexion. These models will aim at predicting disease recurrence for arteries with different patient and lesion characteristics.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 5 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Otro
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Criterios
Inclusion Criteria: * Subjects eligible for participating in this study are patients with severe PAD who have: 1. endovascular repair of their femoropopliteal artery 2. standard pre-operative contrast-enhanced thin-section CTA of the lower extremities 3. intraoperative angiograms and blood pressure measurements proximal and distal to the stent during the endovascular repair 4. no aneurysmal disease of the target femoropopliteal artery 5. no prior open or endovascular repair of the target femoropopliteal artery (patients with re-interventions are not eligible) 6. at least 2 out of 3 patent crural outflow vessels 7. life expectancy \>6 months 8. no iodinated contrast allergy 9. creatinine less than 1.6 g/dL (unless on chronic dialysis, dialysis patients are eligible) 10. no orthopedic prostheses in the region of interest 11. ability to comply with 6-12-month follow-up contrast enhanced thin-section CTA Exclusion Criteria: 1. no endovascular repair of the femoropopliteal artery 2. endovascular or open re-intervention in the target limb 3. no pre-operative thin-section contrast-enhanced CTA of the target limb 4. no intraoperative angiogram or blood pressure measurements proximal and distal to the stent 5. aneurysmal disease of the target femoropopliteal artery 6. less than 2 patent crural outflow vessels 7. life expectancy ≤ 6 months 8. iodinated contrast allergy 9. orthopedic prosthesis in the region of interest 10. creatinine greater than 1.6 g/dL (unless dialysis patient, chronic dialysis patients are eligible) 11. inability to comply with 6-12-month contrast-enhanced CTA follow-up requirement 12. patient belongs to vulnerable population, i.e. pregnant women, prisoners, institutionalized individuals
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
University of Nebraska Medical Center
Omaha, United StatesAbrir University of Nebraska Medical Center en Google Maps