Condition: Aortic Aneurysm · Aortic Aneurysm and Dissection · Aortic Diseases · Sponsor: Vascutek Ltd.
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.
This description comes directly from the study's public registry record.
Sarah Macluskie · +441413430333 · s.macluskie@terumoaortic.com
Michelle Durnan · +44 141 343 0184 · m.durnan@terumoaortic.com
Always discuss trial participation with your own doctor first.
| Keck Medicine of USC | Los Angeles, California, United States | Not Yet Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Not Yet Recruiting |
| University of Colorado Anschutz Medical Campus | Aurora, Colorado, United States | Not Yet Recruiting |
| Medstar Washington Hospital Center | Washington D.C., District of Columbia, United States | Not Yet Recruiting |
| UF Health Shands Hospital | Gainesville, Florida, United States | Not Yet Recruiting |
| Tampa General Hospital | Tampa, Florida, United States | Not Yet Recruiting |
| Northwestern Memorial Hospital | Chicago, Illinois, United States | Not Yet Recruiting |
| Johns Hopkins Hospital | Baltimore, Maryland, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Not Yet Recruiting |
| Barnes-Jewish Hospital | St Louis, Missouri, United States | Recruiting |
| Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania, United States | Recruiting |
| UPMC Presbyterian | Pittsburgh, Pennsylvania, United States | Not Yet Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07078383