Lifeline Registry: collaborative evaluation of endovascular aneurysm repair.
OBJECTIVE
The purpose of this study is to collect and analyze long-term outcome data on the safety and effectiveness of endovascular grafts used in abdominal aortic aneurysm repair in the United States and Canada. We aimed to help define appropriate patients for endograft therapy and to evaluate long-term device performance and patient outcome, thereby contributing to improving the care of patients with abdominal aortic aneurysms.


METHODS
Data entered in the Registry include the electronic data collected under the endovascular graft manufacturers' clinical trials, prospective follow-up data of patients enrolled in these trials, both from the clinical centers and from interviews conducted at New England Research Institutes, and explant data, obtained primarily from analyses conducted by the Registry central pathology laboratory.


METHODS
The Registry records and analyzes the long-term follow-up data of patients in the clinical trials that lead to devices approved by the Food and Drug Administration. The Registry has also launched a feasibility study to expand the Registry to include patients receiving commercial endovascular grafts, the devices available following Food and Drug Administration marketing approval.
D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods / Q000592:standards* / Q000706:statistics & numerical data*; D017544:Aortic Aneurysm, Abdominal / Q000453:epidemiology / Q000601:surgery*; D014487:Centers for Medicare and Medicaid Services, U.S.; D002986:Clinical Trials as Topic; D004282:Documentation; D004869:Equipment Safety; D005240:Feasibility Studies; D017408:Guidelines as Topic; D006801:Humans; D007373:Interinstitutional Relations; D009316:National Institutes of Health (U.S.); D011446:Prospective Studies; D012042:Registries / Q000592:standards / Q000706:statistics & numerical data; D012449:Safety; D017749:Total Quality Management; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration