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NCT04545502 · ClinicalTrials.gov registry record

PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

A clinical trial of Aortic Diseases and Aneurysm, sponsored by Vascutek.

Recruiting
Registry status
2,000
Enrollment target
20
Study locations

NCT04545502: Recruiting study of Aortic Diseases and Aneurysm, sponsored by Vascutek.

NCT04545502 is a study of Aortic Diseases and Aneurysm that is actively recruiting participants, run by Vascutek. The registered enrollment target is 2,000 participants, above the 1,266-participant average among 7 other Aortic Diseases trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04545502, a study of Aortic Diseases and Aneurysm, is actively recruiting participants, sponsored by Vascutek.

RECRUITING
Registry status
2,000 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice. Data will be collected both retrospectively and prospectively.

Primary Outcome

30 Day or In-Hospital Mortality

Interventions

  • DEVICE Gelsoft Plus Vascular Graft
  • DEVICE Vascular Bypass Graft
  • DEVICE Cardiovascular Patch
  • DEVICE Gelweave Vascular Graft
  • DEVICE Gelweave Valsalva Vascular Graft

Study Locations (20)

Other

  • UZ Gent - Ghent
  • AZ Groeninge Kortrijk - Kortrijk
  • UZ Leuven - Leuven
  • CHU Bordeaux - Bordeaux
  • CHU Clermont Ferrand - Clermont-Ferrand
  • CHU de Dijon - Dijon
  • CHU de Lille - Lille
  • Hôpital Nord Marseille - Marseille
  • CHU de Rennes - Rennes

North Carolina

  • Duke University - Durham
  • East Carolina University - Greenville

Ohio

  • University Hospitals Cleveland Medical Center - Cleveland
  • Ohio State University - Columbus

Pennsylvania

  • Lehigh Valley Hospital - Allentown
  • University of Pennsylvania - Philadelphia

Colorado

  • University of Colorado Anschutz - Aurora

Florida

  • University of South Florida - Tampa General - Tampa

Indiana

  • Indiana University Health - Indianapolis

Virginia

  • Virginia Commonwealth University - Richmond

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2021-02-17
Est. Completion 2037-01
Vascutek

4 total trials

What NCT04545502 shows while recruiting

NCT04545502 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 1,266-participant average among 7 other Aortic Diseases trials with a reported enrollment target (58% higher).

The record links to 9 conditions, with Aortic Diseases appearing as the primary indexed condition, and to 5 interventions - of which Gelsoft Plus Vascular Graft is the first listed.

NCT04545502 names 20 study sites across 9 states, led by Other, North Carolina, Ohio.

Frequently Asked Questions

What is clinical trial NCT04545502 about?

NCT04545502 is a clinical study titled "PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches". The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice. Data will be collected both retrospectively and prospectively.

What is the current status of trial NCT04545502?

This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2021-02-17. Estimated completion is 2037-01.

What conditions does trial NCT04545502 study?

This clinical trial studies the following conditions: Aortic Diseases, Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection.

What interventions are being tested in trial NCT04545502?

The interventions under investigation include: Gelsoft Plus Vascular Graft (DEVICE), Vascular Bypass Graft (DEVICE), Cardiovascular Patch (DEVICE), Gelweave Vascular Graft (DEVICE), Gelweave Valsalva Vascular Graft (DEVICE).

Who is sponsoring clinical trial NCT04545502?

This trial is sponsored by Vascutek, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04545502 being conducted?

This trial has 20 study locations across Colorado, Florida, Indiana, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04545502, the US trial registry maintained by the National Library of Medicine. NCT04545502 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.