Actively Recruiting
Evaluation of the Rapidlink Device for Use in Repair or Replacement of Supra-Aortic Vessels During Open Surgery of the Thoracic Aorta
Led by Vascutek Ltd. · Updated on 2026-02-06
150
Participants Needed
23
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of the Rapidlink device in patients who need repair or replacement of the supra-aortic vessels during open surgery for thoracic aortic disease. This includes conditions affecting the aortic arch, where traditional surgery can be challenging. The study aims to simplify and speed up the connection of grafts to these vessels using the Rapidlink device, which may reduce the need for extra surgical steps. The Rapidlink device consists of a Gelweave graft attached to a stented section with nitinol rings, delivered via a single-use system. The study includes two groups: up to 120 patients undergoing elective surgery and up to 30 patients undergoing emergency surgery. Initially, the first 32 elective patients will receive the device for left subclavian artery repair only. After that, enrollment will expand to include repair of any supra-aortic vessel in elective cases. Emergency cases will be enrolled after the first 32 elective cases. Participants will be evaluated before surgery, during the implant, at hospital discharge or 30 days, and at 3, 6, 12, and 24 months after surgery. Researchers will monitor major adverse events at 6 months, technical and clinical success of the device, rates of stroke, vessel rupture, device-related complications, and other clinical outcomes. Data collection includes assessments during hospital recovery and follow-up visits for up to 2 years.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is aged 18 years or over on date of consent
- Written informed consent to participate in the study
- Need for open surgical repair of the thoracic aorta using Gelweave graft or Thoraflex Hybrid device
- Anticipated use of Rapidlink for repair or replacement of left subclavian artery, left common carotid artery, and/or innominate artery
- Patient's target supra-aortic vessel(s) diameter within specified ranges
- Patient has 8-15 mm inner diameter of target supra-aortic vessel(s)
You will not qualify if you...
- No clear landing zone free from stenosis, calcification, or thrombus for the implantable stent length
- No sealing zone free from tortuosity
- Significant vessel angulation greater than 79° with internal radius less than 6mm
- Unable to receive anticoagulation or antiplatelet therapy during or after procedure
- Uncontrolled hypercoagulation
- Condition preventing necessary imaging
- Anatomic variants compromising circulation after device placement unless planned or revascularized
- Unfit for open surgery involving circulatory arrest
- Known sensitivity to polyester, nitinol, tantalum, or bovine materials
- Ruptured aorta
- Active endocarditis or infective disorder of the aorta
- Active systemic infection compromising surgery outcome
- Enrolled in another active study with investigational product within 6 months or not reached primary endpoint
- Female who is pregnant or plans pregnancy during study without contraception
- Uncorrectable bleeding anomaly
- Renal failure requiring dialysis or high serum creatinine
- Sensitivity to radiopaque contrast agents that cannot be pre-treated
- Co-morbidity with expected survival less than 1 year
- Other medical, social, or psychological problems precluding treatment or evaluations
- Known chronic aortic dissection involving intended landing zone of target vessel(s)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure plus hospital stay until discharge
Participants undergo open surgical repair or replacement of the supra-aortic vessels using the Rapidlink device during aortic surgery, followed by immediate post-operative care.
1 surgical visit and hospital stay
Duration - Up to 24 months following surgery
Participants are monitored for safety and effectiveness of the Rapidlink device after surgery.
Visits at discharge/30 days, 3 months, 12 months, and 24 months post-procedure
Trial Site Locations
Total: 23 locations
1
Keck Medicine of USC
Los Angeles, California, United States, 90033
Not Yet Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Not Yet Recruiting
4
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Not Yet Recruiting
5
UF Health Shands Hospital
Gainesville, Florida, United States, 32608
Not Yet Recruiting
6
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Not Yet Recruiting
7
Tampa General Hospital
Tampa, Florida, United States, 33606
Not Yet Recruiting
8
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Not Yet Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02129
Not Yet Recruiting
10
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
11
Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
12
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
13
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15232
Not Yet Recruiting
14
Acension Seton Medical Center
Austin, Texas, United States, 78705
Not Yet Recruiting
15
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, United States, 75093
Not Yet Recruiting
16
Froedhert Hospital
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
17
University Hospital Vienna
Vienna, Austria, 1090
Not Yet Recruiting
18
University Medical Center Freiburg
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
19
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Not Yet Recruiting
20
Robert Bosch Hospital
Stuttgart, Germany, 70376
Not Yet Recruiting
21
Radboud University Medical Center
Nijmegen, Radboud, Netherlands
Not Yet Recruiting
22
University Hospital of Bern
Bern, Switzerland, 3010
Not Yet Recruiting
23
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
Research Team
S
Sarah Macluskie
M
Michelle Durnan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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