| NCT ID | NCT04875429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cook Research Incorporated |
| Condition | Aortic Aneurysm, Abdominal |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2023-12-08 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 105 participants in total. It began in 2023-12-08 with a primary completion date of 2026-11.
⚠ 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 Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. Up to 60 additional subjects may be enrolled in Continued Access phase of the study
Eligibility Criteria
Include Criteria: 1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females 2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months 3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator Exclusion Criteria: 1. Age \< 18 years 2. Life expectancy \< 2 years 3. Pregnant, breast-feeding, or planning to become pregnant within 60 months 4. Inability or refusal to give informed consent by the patient or legally authorized representative 5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging 6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
Contact & Investigator
Gustavo Oderich, MD
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT04875429 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Aneurysm, Abdominal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04875429 currently recruiting?
Yes, NCT04875429 is actively recruiting participants. Contact the research team at chanda.bell@cookmedical.com for enrollment information.
Where is the NCT04875429 trial being conducted?
This trial is being conducted at Birmingham, United States, La Jolla, United States, Los Angeles, United States, Stanford, United States and 11 additional locations.
Who is sponsoring the NCT04875429 clinical trial?
NCT04875429 is sponsored by Cook Research Incorporated. The principal investigator is Gustavo Oderich, MD at Baylor College of Medicine. The trial plans to enroll 105 participants.