Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR...
Abdominal Aortic AneurysmThe objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.
Framing Eighteen Coils in Cerebral Aneurysms Trial
Cerebral AneurysmThis trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155" platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014" (with a standard diameter). Hypothesis: Angiographic occlusion at follow-up imaging will be more frequent in patients receiving 0.014-0.0155" platinum coils during embolization compared to those receiving smaller-diameter coils.
Dual Antiplatelet Therapy Adherence With Reminder App Usage
Aneurysm Cerebral (Unruptured)The purpose of this study is to evaluate Dual Antiplatelet Therapy adherence in patients undergoing stent-based endovascular treatment for unruptured cervical and intradural, intracranial aneurysms. Patients will be randomized on a 1:1 basis to either a medication reminder app group or a control group, with patients in both groups receiving the standard of care. The app in question, Endovascular Neurosurgery, is available on the app store. The app does not collect user data and has not been officially deemed HIPAA compliant. The only data inputted into the app are the patient's procedure date and the antiplatelet medications the patient has been prescribed. The app does not possess sensitive patient data. Patients will input the time notifications will be sent and the app will be available in both Spanish and English. The investigators will be assessing medication adherence via the Adherence Barriers Questionnaire.
DOTATATE PETMRI AAA Study
Abdominal Aortic AneurysmAbdominal Aortic Aneurysm (AAA) screening and an aging population have increased the prevalence of AAA diagnoses. Small AAAs (<5.5cm) are monitored with ultrasound. Large AAAs may rupture and this is usually fatal. Surgery is considered at a crude size threshold of 5.5cm when the annual rupture risk reaches 5%. AAA size is the only predictor of growth and rupture available but growth is non-linear and some small AAAs rupture. Thus, only 1 in 20 patients treated at 5.5cm will have benefited from rupture prevention in the year following surgery, and others may miss out on life-saving surgery. This study will develop an imaging tool PETMRI with radiotracer Ga- DOTATATE with high clinical utility, to improve prediction of aneurysm growth and risk.
Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel...
Abdominal Aortic AneurysmThe primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.
NIH CCR2 AAA Study
Abdominal Aortic Aneurysm (AAA)No Abdominal Aortic Aneurysm (Non-AAA)Abdominal aortic aneurysm (AAA) is a degenerative vascular disease, which is typically asymptomatic until rupture, resulting in high mortality. AAAs are more prevalent in men over age 65, though rupture is disproportionately higher in women. Due to nonlinear and unpredictable aortic dilatation, it is challenging to predict the AAA rupture using clinical diagnostics based on morphology. No medical therapy is used clinically to treat AAA, and there is an unmet need for clinically translatable, molecular biomarkers of AAA disease activity for surveillance and patient-specific management. The goal of this proposal is to develop a new approach for the diagnosis and targeted therapy of AAA.
Impact of Neurochecks on Sleep in Critically Ill Adults
Cerebral AneurysmBackground: Following acute brain injury (ABI), patients are monitored in the intensive care unit (ICU) where providers rely on frequent neurological examinations ("neurochecks") to assess for neurodeterioration. Serial neurochecks are part of guideline recommendations, but there is equipoise between hourly (Q1) and every-other-hour (Q2) evaluation. In the ICU, care-related awakenings occur frequently, but it is unclear if differential neurocheck frequencies result in differential sleep, providing the scientific premise for this proposal. Population: Twenty-two patients (N=11 per group) who have undergone elective aneurysm coiling will be enrolled. On post-operative day (POD) 0, patients will be screened and approached for informed consent if they do not meet exclusion criteria, e.g., prior intracranial injury, sleep disorders, cognitive impairment, mechanical ventilation. Patients with elective aneurysm coiling are being chosen because they require ICU level of care following their intracranial procedure, but do not have structural brain injury or ongoing sedation needs that might impact sleep measurements. Methods: Usual care: Patients are monitored every 15-30 minutes for up to 6 hours post-procedure, then Q1 or Q2 for up to 24 hours. If these patients remain stable, they are discharged home on post-operative day (POD) 1. Proposed Intervention: Enrolled patients will be randomized to Q1 or Q2 neurochecks following the institutionally required 6 hours of stable neurological and vascular checks. Once randomized, patients will undergo placement of electroencephalogram (EEG) with video, electrooculogram, and chin lead. The video EEG will be in place for at least 8 hours to include the overnight (10PM-6AM) time period. Following completion of the recording, the signals obtained will be reviewed by a blinded polysomnographic sleep technician for sleep characteristics including quantitative assessments of wakefulness, deep (N3) sleep, REM sleep, sleep efficiency, and sleep fragmentation and arousals. On POD1, patients and their nurse will fill out the Richards-Campbell Sleep Questionnaire to rate subjective sleep quality.
Visceral (Kidney and Abdominal Organ) Function After Fenestrated and Branched Endovascular Aneurysm...
Aortic AneurysmAbdominalThe purpose of this study is to evaluate visceral function, after endovascular repair of thoracoabdominal aneurysms.
A PMCF Study in Patients With Thoracoabdominal Aortic Aneurysms Treated With E-nside TAAA Multibranch...
Thoracoabdominal Aortic AneurysmThe INNER-B-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of the E-nside TAAA Multibranch Stent Graft System used in endovascular treatment of patients with thoracoabdominal aortic aneurysms.
SEAL™ IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
AneurysmTo establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms. The data from this study will be used to support a premarket approval (PMA) submission.