COAST: COILING OF ANEURYSMS SMALLER THAN 5 MM WITH
Rationale and Intervention:This is a prospective, single-arm, multi-center post-marketing data collection study to determine the safety and effectiveness of HyperSoft and HydroFrame/HydroSoft coils in the treatment of small intracranial aneurysms. HyperSoft Helical, HyperSoft 3 D and HydroFram/HydroSoft are newly designed coils where the shape and softness of these coils are designed for small aneurysms. There are 2 phases in this study. In Phase 1, participants will be enrolled if they will be treated with HyperSoft 3D and HyperSoft helical coils. When the sponsor adds phase 2, patients will be enrolled into Phase 2 if their aneurysm will be framed with HydroFrame HydroSoft 3D and finished with HyperSoft 3D and /or Hyper Soft helical coils. Objectives:The primary objective of this study is to assess clinical and imaging outcomes in the endovascular treatment of small ( 4.9 mm) intracranial aneurysms utilizing the HyperSoft 3D and HyperSoft helical coils specifically designed for the treatment of small aneurysms.Study Population: 300 participants who have been diagnosed with small ( 4.9 mm) intracranial aneurysms and who were treated with the coils from 16 centers. Study Methodology:Endovascular coiling of the aneurysm is performed per each institutions standard procedure.Data from each participant will be collected up to 12 months post procedure. There are up to five data points which include baseline (pre- procedure), procedure/post procedure through discharge and follow-up at 6 or 12 months. Data from imaging (2-D DSA, diagnostic) of aneurysm, clinical assessment (mRS, Hunt & Hess,NIHSS), aneurysm occlusion grading (Raymond-Roy grading scale /RRGS), retreatment and adverse events/safety will be collected per protocol at various time points. Study Endpoints or Outcomes:Efficacy: Raymond-Roy grading scale (RRGS) of 2 or better occlusion on follow-up angiography performed >150 days post embolization, not requiring retreatment.Safety: Freedom from new post-procedural bleeding and ischemic stroke associated with a 4-point worsening neurologically within 48 hours of aneurysm treatment or any new aneurysmal bleeding secondary to treated aneurysm. Follow up:All Study subjects will undergo follow-up angiographic (DSA or MRA) evaluations at 6 months and/or 12 months following the procedure or if an unscheduled visit is required.Statistics and Plans for Analysis:Two-sided 95% confidence intervals will be calculated about the estimated post EVT occlusion rates using the exact binomial distribution. Secondary analyses will include any neurological and mortality, bleeding rate of target aneurysms at one year (includes rebleeding of target ruptured aneurysms), recurrence rate/recanalization (at time of >150 day angiographic follow up), and retreatment rate (at one year). All clinical outcome analyses will be performed on the per protocol and ITT populations.
GREAT Global Registry for Endovascular Aortic TreatmentOutcomes Evaluation
This is a retrospective and prospective observational cohort Registry designed to obtain
data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System. Patient
and device performance outcomes will be collected during treatment and throughout all
post-treatment visits, including follow-up extending up to 10 years.
Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial
Abdominal aortic aneurysms (AAAs) are a common and life-threatening condition. The rate of aneurysm growth and the risk of rupture are related to aneurysm size. Aortic diameter is the single best predictor of rupture risk. AAAs are typically asymptomatic and spontaneous rupture of an aneurysm is usually fatal. A number of antibiotics have been proposed as a treatment for AAA with varying rationales. One line of reasoning is that AAA progression is enhanced by secondary infection within the aortic wall. Chlamydia pneumonia has been found in atherosclerotic plaque and the wall of abdominal aortic aneurysms. The tetracycline antibiotics have been studied because of their known inhibition of matrix metalloproteinases (MMP). Although studies in mice and rats have shown that doxycycline can slow down the growth of aneurysms, there have only been a few small studies in humans that have not provided a definitive answer. The purpose of the study is to determine whether doxycycline administration can decrease the rate of growth of small abdominal aortic aneurysms. About 250 participants aged 55 and older with a small abdominal aortic aneurysm will be enrolled in this study; about 20 participants at USC. Participants will be randomized to doxycycline or placebo. Participants will be followed for two years with imaging studies and lab tests for various biomarkers as well as qualify of life questionnaires. in addition, they will be monitored for adverse events. The primary study endpoint is the transverse diameter of the aneurysm over the two year period. Secondary endpoints will include evaluation of biomarkers and quality of life. The sponsor will conduct the statistical analysis to assess the safety and efficacy of doxycycline, the change in size of aneurysm.