NCT01937949 Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts
| NCT ID | NCT01937949 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gustavo S Oderich |
| Condition | Juxtarenal Aortic Aneurysms |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2013-08 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2013-08 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.
Eligibility Criteria
General Inclusion Criteria * A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft: * Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter * Aneurysm with a history of growth ≥ 0.5 cm per year * Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation. General Exclusion Criteria * Less than 18 years of age * Unwilling to comply with the follow-up schedule * Inability or refusal to give informed consent by the patient or a legally authorized representative * Pregnant or breastfeeding * Life expectancy \< 2-years * Additional medical restrictions as specified in the Clinical Investigation Plan * Additional anatomical restrictions as specified in the Clinical Investigation Plan
Contact & Investigator
Gustavo S. Oderich, MD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT01937949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Juxtarenal Aortic Aneurysms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01937949 currently recruiting?
Yes, NCT01937949 is actively recruiting participants. Contact the research team at andrea.martinez@bcm.edu for enrollment information.
Where is the NCT01937949 trial being conducted?
This trial is being conducted at Rochester, United States, Houston, United States.
Who is sponsoring the NCT01937949 clinical trial?
NCT01937949 is sponsored by Gustavo S Oderich. The principal investigator is Gustavo S. Oderich, MD at Baylor College of Medicine. The trial plans to enroll 200 participants.