Zenith® Fenestrated+ Clinical Study
The Zenith® Fenestrated+ Endovascular Graft (ZFEN+) clinical study assesses 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 m...
About This Study
Summary
The ZFEN+ clinical study is a prospective, multi-center, single-arm study that includes 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.
To be included in ZFEN+, participants must be / have
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
To be included in ZFEN+, participants must not be / have
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
Keywords
Aneurysm-related mortality; Aortic aneurysms; BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System; Endovascular graft; Single-arm; Visceral arteries
For More About This Study or To Ask About Participation
Lead scientist at Carilion Clinic
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.
Official title of study
Zenith® Fenestrated+ Endovascular Graft Clinical Study
Funding mechanism
Industry sponsored by Cook Medical