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
Condition(s) studied
Investigational drug(s) / intervention(s)
Rapidlink: The Rapidlink implant is comprised of a Gelweave graft section (gelatin-sealed woven polyester) attached to a stented section (which utilizes nitinol ring stents), with a 'cuff'' feature joined to the stented section of the implant. The implant is supplied pre-loaded in a single use delivery system which compacts the stented section within a polytetrafluoroethylene (PTFE) sheath at the front of the system.
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.
Eligibility
Primary outcome measure(s)
- The absence of a major adverse event (MAE) at 6-month post procedure. — 6 months post procedure
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
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Keck Medicine of USC | Los Angeles | California | Not Yet Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Not Yet Recruiting |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | Not Yet Recruiting |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | Not Yet Recruiting |
| UF Health Shands Hospital | Gainesville | Florida | Not Yet Recruiting |
| Tampa General Hospital | Tampa | Florida | Not Yet Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | Not Yet Recruiting |
| Johns Hopkins Hospital | Baltimore | Maryland | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Not Yet Recruiting |
| Barnes-Jewish Hospital | St Louis | Missouri | Recruiting |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | Recruiting |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | Not Yet Recruiting |
| Acension Seton Medical Center | Austin | Texas | Recruiting |
| Baylor Scott & White The Heart Hospital - Plano | Plano | Texas | Recruiting |
| Froedhert Hospital | Milwaukee | Wisconsin | Recruiting |
| University Hospital Vienna | Vienna | Austria | Not Yet Recruiting |
| University Medical Center Freiburg | Freiburg im Breisgau | Germany | Not Yet Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Not Yet Recruiting |
| Robert Bosch Hospital | Stuttgart | Germany | Not Yet Recruiting |
| Radboud University Medical Center | Nijmegen | Radboud | Recruiting |
| St Bartholomew's Hospital | London | United Kingdom | Not Yet Recruiting |
More Vascutek Ltd. trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07078383 on ClinicalTrials.gov ↗ ← All trials in the UK