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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 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.

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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

Conditions Studied

Aortic Aneurysm, Abdominal Juxtarenal Aortic Aneurysm Pararenal Aneurysm Extent IV Thoracoabdominal

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

FieldValue
Enrollment Target 105 participants
Start Date 2023-12-08
Est. Completion 2031-11
Phase NA

Sponsor

Cook Research Incorporated

24 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04875429

The ClinicalTrials.gov registry entry for NCT04875429 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 141-participant average among 8 other Aortic Aneurysm, Abdominal trials with a reported enrollment target (26% lower). The listed sponsor is Cook Research Incorporated, which has 24 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.