Endovascular Graft Repair for Aortic Aneurysm
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary objective of this study is to assess the use of a physician-modified Cook Alpha Thoracic Endovascular Graft in the repair of complex aortic aneurysms and thoracoabdominal aortic aneurysms and aneurysms secondary to aortic dissections in high-risk patients having appropriate anatomy. The primary intent of the study is to assess the safety and preliminary effectiveness of the device. Additionally, the study will assess renal function, radiation exposure, and quality of life.
Do I need to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data is available for the Zenith Alpha Thoracic Endovascular Graft?
Several studies have evaluated the safety of the Zenith Alpha Thoracic Endovascular Graft. A one-year international multicenter study assessed its safety and effectiveness for treating descending thoracic aortic aneurysms and large ulcers. The TRANSFIX study provided updated safety results for treating blunt thoracic aortic injuries (BTAI) with this device. Another study reported 30-day safety outcomes for BTAI treatment. Additionally, initial clinical experiences in Europe evaluated the safety and efficacy of the low-profile version of the graft for thoracic endovascular aortic repair.12345
Is the Zenith Alpha Thoracic Endovascular Graft safe for humans?
Is the treatment Zenith Alpha Thoracic Endovascular Graft a promising treatment for aortic aneurysm?
How is the Zenith Alpha Thoracic Endovascular Graft treatment different from other treatments for aortic aneurysm?
The Zenith Alpha Thoracic Endovascular Graft is unique because it is a low-profile device, meaning it is smaller and more flexible, which makes it suitable for patients with smaller or diseased blood vessels. This design allows for a less invasive procedure compared to traditional surgical methods, potentially reducing recovery time and complications.12346
What data supports the idea that Endovascular Graft Repair for Aortic Aneurysm is an effective treatment?
The available research does not provide any data on Endovascular Graft Repair for Aortic Aneurysm. Instead, it focuses on treatments for brain metastases from lung cancer, such as gamma knife radiosurgery and whole-brain radiotherapy. Therefore, there is no information here to support the effectiveness of Endovascular Graft Repair for Aortic Aneurysm.7891011
Who Is on the Research Team?
Javairiah Fatima, M.D
Principal Investigator
Medstar Health Research Institute
Are You a Good Fit for This Trial?
This trial is for adults with large aortic aneurysms who are at high risk for open surgery. Candidates must have a life expectancy over 2 years, compatible anatomy for the device, and no severe allergies to device materials. Pregnant or breastfeeding individuals, those with certain connective tissue diseases or infections, and those unable to undergo imaging tests due to body size are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Endovascular repair of complex aortic aneurysms using a physician-modified endovascular graft
Follow-up
Participants undergo periodic follow-up evaluations involving physical exams, CTA, abdominal duplex ultrasound, creatinine measurement, and quality of life questionnaire
What Are the Treatments Tested in This Trial?
Interventions
- Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft
Physician-Modified Cook Zenith Alpha Thoracic Endovascular Graft is already approved in European Union, United States, Canada for the following indications:
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Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor