Zenith® Fenestrated+ Endovascular Graft for Treatment of Aortic Aneurysms in Combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System
About
The Zenith® Fenestrated+ Endovascular Graft (ZFEN+) clinical study will assess the safety and effectiveness of the ZFEN+ in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.
The ZFEN+ clinical study is a prospective, multi-center, single-arm study that will include sites in the United States and Europe. At this time, the U.S. Food and Drug Administration (FDA) has approved enrollment of the first 30 patients. Ultimately, Cook Medical intends to enroll 102 patients in the pivotal study.
The primary safety endpoint is a composite measure—a group of variables collected during the clinical study and analyzed—of device technical success and procedural safety within 30 days. Likewise, the primary effectiveness endpoint is a composite measure of freedom from aneurysm-related mortality and freedom from clinically significant reintervention through 12 months post-procedure.
Eligibility Criteria
Inclusion Criteria
Patients must meet ALL the inclusion criteria to be considered for the study:
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 50 mm
- Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months
- 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
If ANY of the exclusion criteria are met, the patient cannot be enrolled in this study:
- Age < 18 years
- Life expectancy < 2 years
- Pregnant, breastfeeding or planning to become pregnant within 60 months
- Inability or refusal to give informed consent by the patient or legally authorized representative
- Unwilling or unable to comply with the follow-up schedule, required clinical assessments and imaging
- Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study
Primary Investigator
Dr. Esmaeel Reza Dadashzadeh is a dual board-certified vascular surgeon with a strong background in both clinical care and research. He’s currently the interim director of the Carilion Clinic Aortic Center and interim section chief of Aortic and Endovascular Surgery. In addition to his clinical roles, he’s an assistant professor of Aortic and Endovascular Surgery at Virginia Tech Carilion School of Medicine.
Dr. Dadashzadeh completed his vascular surgery fellowship at Washington University in St. Louis and his general surgery residency at the University of Pittsburgh Medical Center. He also holds a master’s in biomedical informatics from the University of Pittsburgh.
Contact Information
Yili Zhong, Ph.D.
Clinical Research Coordinator
