Actively Recruiting
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
Led by Vascutek Ltd. · Updated on 2026-02-06
150
Participants Needed
23
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Patient requires open surgical repair of the thoracic aorta using Gelweave graft or Thoraflex Hybrid device
- Anticipated use of Rapidlink device for repair or replacement of left subclavian artery, left common carotid artery, and/or innominate artery
- Patient has target supra-aortic vessel(s) with an inner diameter of 8-15 mm
- Vessel diameters fall within the ranges specified in the device instructions for use
You will not qualify if you...
- No clear landing zone free from stenosis, calcification, or thrombus for implantable stent length
- No sealing zone free from tortuosity
- Significant angulation greater than 79° with internal radius less than 6 mm for full stent length
- Unable to receive anticoagulation or antiplatelet therapy during or after procedure
- Uncontrolled hypercoagulation
- Conditions preventing necessary imaging
- Anatomic variants compromising circulation to first branch off target artery unless planned or revascularized
- Unfit for open surgical repair involving circulatory arrest
- Known sensitivity to polyester, nitinol, tantalum, or bovine materials
- Ruptured aorta
- Active endocarditis or active aortic infection
- Active systemic infection compromising surgical outcome
- Participation in another active study with investigational product within 6 months or not reached primary endpoint
- Female who is pregnant or planning pregnancy during study; females of childbearing potential must use contraception
- Uncorrectable bleeding disorder
- Renal failure requiring dialysis or serum creatinine ≥2.5 mg/dL
- Known sensitivity to radiopaque contrast agents that cannot be pre-treated
- Co-morbidity causing expected survival less than 1 year
- Any medical, social, or psychological condition precluding participation
- Known chronic aortic dissection involving intended landing zone of target vessel(s)
AI-Screening
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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
CONTACT
M
Michelle Durnan
CONTACT
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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