SFAOptimal Stent Selection for the Femoropopliteal Artery
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveAutre
Méthodes concernant des questions de recherche très spécifiques.Résumé
Date de début de l'étude : 2 septembre 2014
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.5 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Autre
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
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 l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
University of Nebraska Medical Center
Omaha, United StatesOuvrir University of Nebraska Medical Center dans Google Maps