New device aims to make aortic surgery safer

NCT ID NCT07078383

Disease control Sponsor: Vascutek Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 5 times

Summary

This study tests a new device called Rapidlink, used during open surgery to repair or replace blood vessels in the chest. It involves 150 adults already scheduled for aortic surgery. The goal is to see if the device reduces major complications like stroke or death. Participants will be followed for two years after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Rapidlink device (a stent-graft implant used during open aortic surgery)
What this could lead to: If successful, this device could make aortic arch repairs safer and more reliable, reducing complications like stroke or paralysis.
What could go wrong: This is an early-stage study with only 150 participants, so results may not apply to everyone. Risks include stroke, paralysis, or device-related problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Aneurysm aortic aneurysm aortic disorder Aortic Dissection familial thoracic aortic aneurysm and aortic dissection thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysm of aorta, thoracic Aneurysmal disease Aorta, thoracic pathologies Aortic aneurysm Aortic aneurysm and dissection Aortic diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

21 sites in 5 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Acension Seton Medical Center
RECRUITING

Austin, Texas, 78705, United States
Barnes-Jewish Hospital
RECRUITING

St Louis, Missouri, 63110, United States
Baylor Scott & White The Heart Hospital - Plano
RECRUITING

Plano, Texas, 75093, United States
Cedars-Sinai Medical Center
NOT_YET_RECRUITING

Los Angeles, California, 90048, United States
Froedhert Hospital
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Johns Hopkins Hospital
RECRUITING

Baltimore, Maryland, 21287, United States
Keck Medicine of USC
NOT_YET_RECRUITING

Los Angeles, California, 90033, United States
Massachusetts General Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02129, United States
Medstar Washington Hospital Center
NOT_YET_RECRUITING

Washington D.C., District of Columbia, 20010, United States
Northwestern Memorial Hospital
NOT_YET_RECRUITING

Chicago, Illinois, 60611, United States
Radboud University Medical Center
RECRUITING

Nijmegen, Radboud, Netherlands
Robert Bosch Hospital
NOT_YET_RECRUITING

Stuttgart, 70376, Germany
St Bartholomew's Hospital
NOT_YET_RECRUITING

London, EC1A 7BE, United Kingdom
Tampa General Hospital
NOT_YET_RECRUITING

Tampa, Florida, 33606, United States
UF Health Shands Hospital
NOT_YET_RECRUITING

Gainesville, Florida, 32608, United States
UPMC Presbyterian
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15232, United States
University Hospital Vienna
NOT_YET_RECRUITING

Vienna, 1090, Austria
University Medical Center Freiburg
NOT_YET_RECRUITING

Freiburg im Breisgau, 79106, Germany
University Medical Center Hamburg-Eppendorf
NOT_YET_RECRUITING

Hamburg, 20246, Germany
University of Colorado Anschutz Medical Campus
NOT_YET_RECRUITING

Aurora, Colorado, 80045, United States

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