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NCT05639400 · ClinicalTrials.gov registry record
Thoraflex Hybrid and Relay Extension Post-Approval Study
A clinical trial of Aortic Aneurysm and Aortic Dissection, sponsored by Vascutek.
- Active
- Registry status
- 352
- Enrollment target
- 20
- Study locations
NCT05639400: Active study of Aortic Aneurysm and Aortic Dissection, sponsored by Vascutek.
NCT05639400 is a study of Aortic Aneurysm and Aortic Dissection that is active but no longer recruiting, run by Vascutek. The registered enrollment target is 352 participants, below the 615-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05639400, a study of Aortic Aneurysm and Aortic Dissection, is active but no longer recruiting, sponsored by Vascutek.
- ACTIVE NOT RECRUITING
- Registry status
- 352 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treatment with the Thoraflex Hybrid device with or without extension with a RelayPro NBS stent-graft will be eligible for enrolment and study activities and follow-up regime will follow standard care at each participating site. Participant involvement in the study will last for a total of 10 years from the point at which the Thoraflex Hybrid device is placed.
Primary Outcome
* Permanent disabling stroke (mRS \>2 and an increase in at least one mRS category from the individual's pre-stroke baseline, occurring within 30 days of either index procedure or extension and present at 1-year follow-up)\* Note: If a subject dies prior to 1-year follow-up, their last recorded mRS will be considered their final score * Grade 3 spinal cord ischemia (SVS reporting standards) occurring within 30 days of either index procedure or extension * All-cause mortality (within 1 year of ei
Conditions Studied
Interventions
- DEVICE Thoraflex Hybrid
- DEVICE RelayPro NBS
Study Locations (20)
California
- Cedars-Sinai Medical Centre - Los Angeles
- Keck Medical Centre of USC - Los Angeles
Pennsylvania
- University of Pennsylvania - Philadelphia
- UPMC Presbyterian - Pittsburgh
Texas
- UT Dell Medical / Ascension Texas Cardiovascular - Austin
- Baylor College of Medicine - St. Luke's - Houston
Other
- Paracelsus Medical University - Salzburg
- CHU Nantes - Saint-Herblain
Alabama
- University of Alabama in Birmingham Medical Center - Birmingham
Colorado
- University of Colorado - Aurora
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- Medstar Washington Hospital Centre - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2023-03-17 |
| Est. Completion | 2036-03 |
What the registry record for NCT05639400 still lists
NCT05639400 is an observational study that tracks outcomes without assigning an intervention. The registered 352 participants enrollment target is mid-sized for trials with a published cap, below the 615-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (43% lower).
The record links to 5 conditions, with Aortic Aneurysm appearing as the primary indexed condition, and to 2 interventions - of which Thoraflex Hybrid is the first listed.
NCT05639400 names 20 study sites across 16 states, led by California, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT05639400 about?
NCT05639400 is a clinical study titled "Thoraflex Hybrid and Relay Extension Post-Approval Study". The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or without involvement of the ascending aorta. Patients who undergo treat...
What is the current status of trial NCT05639400?
This trial is currently active not recruiting. The enrollment target is 352 participants. The study started on 2023-03-17. Estimated completion is 2036-03.
What conditions does trial NCT05639400 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm, Thoracic Diseases, Thoracic Aortic Dissection.
What interventions are being tested in trial NCT05639400?
The interventions under investigation include: Thoraflex Hybrid (DEVICE), RelayPro NBS (DEVICE).
Who is sponsoring clinical trial NCT05639400?
This trial is sponsored by Vascutek, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05639400 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05639400's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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