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NCT04875429 · ClinicalTrials.gov registry record · NA
Zenith® Fenestrated+ Clinical Study
A NA study of Aortic Aneurysm, Abdominal and Juxtarenal Aortic Aneurysm, sponsored by Cook Research Incorporated.
- Recruiting
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT04875429: Recruiting NA study of Aortic Aneurysm, Abdominal and Juxtarenal Aortic Aneurysm, sponsored by Cook Research Incorporated.
NCT04875429 is a NA study of Aortic Aneurysm, Abdominal and Juxtarenal Aortic Aneurysm that is actively recruiting participants, run by Cook Research Incorporated. The registered enrollment target is 105 participants, below the 141-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04875429, a NA study of Aortic Aneurysm, Abdominal and Juxtarenal Aortic Aneurysm, is actively recruiting participants, sponsored by Cook Research Incorporated.
- RECRUITING
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
Percent of patients with device technical success and freedom from procedural safety events in the following criteria: 1. Device technical success which includes delivery, deployment, and withdrawal of the device without the need for unanticipated corrective intervention), and 2. Freedom from the following procedural safety events: rupture, aneurysm-related mortality, permanent paraplegia, new onset renal failure requiring dialysis, bowel ischemia requiring surgery, and disabling stroke
Conditions Studied
Interventions
- DEVICE Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
Study Locations (20)
Illinois
- Northwestern Memorial Hospital - Chicago
- Endeavor Health Cardiovascular Institute at Glenbrook Hospital - Glenview
- Loyola University Medical Center - Maywood
- Edward Hospital - Naperville
California
- UC San Diego - La Jolla
- University of Southern California - Los Angeles
- Stanford Hospitals and Clinics - Stanford
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- University of Massachusetts - Worcester
Florida
- University of Florida Shands Hospital - Gainesville
- Tampa General Hospital - Tampa
Alabama
- University of Alabama Birmingham Hospital - Birmingham
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Georgia
- Emory University Hospital - Atlanta
Indiana
- Methodist Hospital of Indiana - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2023-12-08 |
| Est. Completion | 2031-11 |
| Phase | NA |
What NCT04875429 shows while recruiting
NCT04875429 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 141-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (26% lower).
The record links to 4 conditions, with Aortic Aneurysm, Abdominal appearing as the primary indexed condition, and to 1 intervention - of which Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 is the first listed.
NCT04875429 names 20 study sites across 12 states, led by Illinois, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04875429 about?
NCT04875429 is a clinical study titled "Zenith® Fenestrated+ Clinical Study". 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 ao...
What is the current status of trial NCT04875429?
This trial is currently recruiting. It is a NA study. The enrollment target is 105 participants. The study started on 2023-12-08. Estimated completion is 2031-11.
What conditions does trial NCT04875429 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Pararenal Aneurysm, Extent IV Thoracoabdominal.
What interventions are being tested in trial NCT04875429?
The interventions under investigation include: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2 (DEVICE).
Who is sponsoring clinical trial NCT04875429?
This trial is sponsored by Cook Research Incorporated, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04875429 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04875429's enrollment target sits among peer trials
105 6th of 8 higher than 3 of 8 other Aortic Aneurysm, Abdominal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Aneurysm, Abdominal trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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