Outcomes of patients treated with open surgery for complex aortic aneurysms
Clinical Outcomes of Patients Treated With Open Surgical Repair for Complex Aortic Aneurysms
This study looks at how well patients do after having open surgery for complex aortic aneurysms to see what factors affect their recovery and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03446287 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on patients undergoing open surgical repair for complex aortic aneurysms at Mayo Clinic. It is a prospective, non-randomized study where the choice of prosthetic graft and surgical technique is determined by the surgeon's preference. Key metrics such as demographics, clinical presentation, intraoperative details, and postoperative outcomes will be recorded at various time points, including quality of life assessments using the SF-36 form. Follow-up will be conducted through office visits and mailed questionnaires to evaluate long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing elective, emergent, or urgent open surgical repair for complex aortic aneurysms, including specific types of abdominal and thoracoabdominal aortic aneurysms.
Not a fit: Patients who refuse to participate, are under 18 years old, or are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of open surgical repair for complex aortic aneurysms, potentially improving patient outcomes.
How similar studies have performed: While this study follows a well-established surgical approach, the specific focus on complex aortic aneurysms through a comprehensive data collection method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients undergoing elective, emergent or urgent OR for CAAs, including: 1. Abdominal aortic aneurysms (AAA) not eligible for endovascular aneurysm repair (EVAR), including 1) Infrarenal AAA with complex aneurysm morphology 2) Short neck infrarenal AAA 3) Juxtarenal AAA 4) Suprarenal AAA 2. Thoracoabdominal aortic aneurysms (TAAA) (Type I - IV) 3. Chronic aortic dissections Exclusion Criteria: 1. Patients who refuse to participate the study 2. Patients age \< 18 years 3. Pregnant breastfeeding patients
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jill Colglazier, MD — Mayo Clinic
- Study coordinator: Jenny Haen
- Email: RSTEndovascularResearch@mayo.edu
- Phone: 507-422-6798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.