NCT02396199

Zenith® p-Branch® Endovascular Graft Pivotal Study

Zenith® p-Branch® Pivotal Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Cook Research Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Conditions

• Aortic Aneurysm Abdominal

Interventions

Type	Name	Description
DEVICE	Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents	Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Timeline

• Start date: 2015-08-01
• Primary completion: 2021-04-01
• Completion: 2025-01-28
• First posted: 2015-03-24
• Last updated: 2025-02-19
• Results posted: 2022-10-25

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated device study