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NCT07078383 · ClinicalTrials.gov registry record · NA
A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta
A NA study of Aortic Aneurysm and Aortic Diseases, sponsored by Vascutek.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT07078383: Recruiting NA study of Aortic Aneurysm and Aortic Diseases, sponsored by Vascutek.
NCT07078383 is a NA study of Aortic Aneurysm and Aortic Diseases that is actively recruiting participants, run by Vascutek. The registered enrollment target is 150 participants, below the 629-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07078383, a NA study of Aortic Aneurysm and Aortic Diseases, is actively recruiting participants, sponsored by Vascutek.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels. The first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in a planned surgery. After the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) repair or replacement with the Rapidlink device in an emergency setting. Data will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.
Primary Outcome
The primary endpoint is the absence of a major adverse event (MAE) at 6-month post procedure. MAE are defined as follows are will be assessed as composite and individually: Permanent disabling stroke Permanent paraplegia/paraparesis Device-related (Rapidlink) reinterventions All-cause mortality * Device-related mortality (arch graft and/or branch graft) * Procedure-related mortality * Not device or procedure related
Conditions Studied
Interventions
- DEVICE Rapidlink
Study Locations (20)
Other
- University Hospital Vienna - Vienna
- University Medical Center Freiburg - Freiburg im Breisgau
- University Medical Center Hamburg-Eppendorf - Hamburg
- Robert Bosch Hospital - Stuttgart
Florida
- UF Health Shands Hospital - Gainesville
- Baptist Hospital of Miami - Miami
- Tampa General Hospital - Tampa
California
- Keck Medicine of USC - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
- UPMC Presbyterian - Pittsburgh
Texas
- Acension Seton Medical Center - Austin
- Baylor Scott & White The Heart Hospital - Plano - Plano
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Illinois
- Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-12-19 |
| Est. Completion | 2028-11 |
| Phase | NA |
What NCT07078383 shows while recruiting
NCT07078383 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 629-participant average among 14 other Aortic Aneurysm trials with a reported enrollment target (76% lower).
The record links to 6 conditions, with Aortic Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which Rapidlink is the first listed.
NCT07078383 names 20 study sites across 12 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT07078383 about?
NCT07078383 is a clinical study titled "A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta". The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta. This study will collect information on patients who are already ha...
What is the current status of trial NCT07078383?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2025-12-19. Estimated completion is 2028-11.
What conditions does trial NCT07078383 study?
This clinical trial studies the following conditions: Aortic Aneurysm, Aortic Diseases, Aneurysmal Disease, Aortic Aneurysm and Dissection, Aneurysm of Aorta, Thoracic.
What interventions are being tested in trial NCT07078383?
The interventions under investigation include: Rapidlink (DEVICE).
Who is sponsoring clinical trial NCT07078383?
This trial is sponsored by Vascutek, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07078383 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07078383's enrollment target sits among peer trials
150 7th of 14 higher than 8 of 14 other Aortic Aneurysm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Aneurysm 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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