🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT07078383
Recruiting Not applicable

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

NCT07078383 · tracked via the Priya Life Science UK tracker
Sponsor
Vascutek Ltd.
Phase
Not applicable
Started
2025-12-19
Last updated
2026-07-27

Condition(s) studied

Aortic AneurysmAortic Aneurysm and DissectionAortic DiseasesAneurysm of Aorta, ThoracicAneurysmal DiseaseAorta, Thoracic Pathologies

Investigational drug(s) / intervention(s)

Rapidlink

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patient is aged 18 years or over on date of consent * Written informed consent (from patient or a legally authorized representative) to participate in study, documenting willingness and ability to comply with all study procedures and study visits (unless an exemption for emergency cases has been IRB / EC approved) * Patient's need for open surgical repair of the thoracic aorta using a Gelweave graft or a Thoraflex Hybrid device (AnteFlo or Plexus) in line with the applicable IFU * Anticipated need to use Rapidlink for the repair or replacement of the LSA, LCCA and/or IA during the open surgical repair * Patient has an 8-15 mm inner diameter (target SAV) * The diameters of the patient's target supra-aortic vessel(s), fall within the ranges specified in the IFU Exclusion Criteria: * Patient does not have a clear landing zone equal to the implantable stent length which is free from stenosis, calcification or thrombus. * Patient does not have a sealing zone free from tortuosity. * Patient has significant angulation (\>79° with an internal radius of less than 6mm) for the full implantable stent length * Patient cannot receive anticoagulation / antiplatelet therapy during or after the index procedure as per the protocol * Patient has uncontrolled hypercoagulation * Patient has a condition which may compromise or prevent the necessary imaging requirements * Patient has anatomic variants which would compromise circulation to the first branch off the target artery after placement of the Rapidlink device (unless planned and/or otherwise revascularized) * Patient is unfit for open surgical repair involving circulatory arrest per the study investigator * Patient has known sensitivity to polyester, nitinol, tantalum, or materials of bovine origin * Patient has a ruptured aorta * Patient has active endocarditis or an active infective disorder of the aorta * Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure * Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study * Patient is female and is pregnant or planning to become pregnant during the course of the study. Females of childbearing potential must use acceptable methods of contraception during the course of the study. * Patient has an uncorrectable bleeding anomaly * Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.5mg/dL) * Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated * Patient has a co-morbidity causing expected survival to be less than 1 year * Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure * Patient has a known chronic aortic dissection involving the intended landing zone of the target supra-aortic vessel(s)

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
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

Official registry record

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