Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT07064460
Brief Summary:
The purpose of this study is to see if physician modified endovascular grafts (PMEG) can be used safely for the treatment of aortic disorders. The surgeon will modify a commercially available graft tailored to the participant's anatomy for surgery. The researchers will follow participants for 5 years, which will require regular visits to the clinic for follow-up imaging and follow-up blood tests.
Detailed Description:
The primary objective of the clinical investigation Duke CARES Trial is to assess the use of physician-modification of commercially available, off-the-shelf, endovascular stent-grafts to treat juxtarenal, pararenal and paravisceral complex abdominal aneurysms or thoracoabdominal aneurysms in high-risk for open surgery subjects having appropriate anatomy. The primary intent of the study is to assess safety and efficacy of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Additionally, the study will assess domains for improvement of patient selection criteria, device design, operative techniques, and follow-up regimens to benefit patients undergoing complex endovascular aneurysm repair
Main Study - Statistical Cohort Physician Modified Endovascular Grafts are indicated for endovascular repair of juxtarenal, pararenal, paravisceral and thoracoabdominal aneurysms, in high-risk for open surgery subjects having appropriate anatomy as defined in the eligibility section.
Non-statistical cohort Patients with life-threatening aortic disease who have no acceptable surgical or endovascular alternatives will be allowed to receive treatment under this IDE. Enrollment of these patients under the IDE permits systematic data collection and FDA oversight, while their separation from the primary study cohort preserves the integrity of the safety and effectiveness analyses. This approach provides a treatment option for critically ill patients by offering access to a potential therapeutic option within a regulated and monitored environment without compromising the scientific validity of the trial. The patients in this cohort will follow standard of care, which includes follow-up at 1 month, 6 months and then annually. Data collection and presentation in this cohort will be consistent with the primary study cohort; however, data from this cohort will not be included in the statistical analysis.
Study:
NCT07064460
Study Brief:
Protocol Section:
NCT07064460