An interventional study of Rapidlink in Aortic Aneurysm, Aortic Aneurysm and Dissection and Aortic Diseases, sponsored by Vascutek Ltd.. Recruiting at 21 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Vascutek Ltd. (part of Terumo Corporation) · Not applicable, Interventional, and Treatment
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.
Treatment options for pathologies involving the aortic arch include medical management, open surgical repair with vascular grafts (e.g., Gelweave), and frozen elephant trunk procedures (e.g., Thoraflex Hybrid).
During conventional replacement of the aortic arch, branches from the main graft are anastomosed onto the transected main arch vessels. In some circumstances this can be difficult for the surgeon, particularly in the case of the left subclavian artery which can be deep routed and difficult to access due to patient anatomy. It can also be displaced by aneurysmal disease or be fragile and friable secondary to atherosclerotic change.
An unmet need exists regarding the ability to access the supra-aortic vessels (e.g., left subclavian artery) in a timely manner during open surgical repair and to expedite the anastomosis to the arch while reducing the need to perform additional concomitant procedures (e.g., transposition or bypass of the left subclavian artery).
The Rapidlink device is designed to simplify this process by enabling the surgeon to place a stented graft within the supra-aortic vessels and secure it, with minimal sutures and manipulation, in a timely manner during open surgical repair.
This study will evaluate patients necessitating repair or replacement of the supra-aortic vessels (i.e., left subclavian artery, left common carotid artery, and/or innominate artery) during open surgical repair of aortic disease affecting the thoracic aorta in an elective (Primary Arm) or emergent (Emergent Arm) setting
Up to 120 subjects will be recruited in the primary arm (elective setting).The first 32 subjects will undergo left subclavian artery repair or replacement with the Rapidlink device. After the 32nd subject with only the left subclavian artery repair or replacement with the Rapidlink device has been enrolled, 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 an elective setting.
For the Emergent Arm, 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 emergent setting. Enrollment into the Emergent Arm will begin after the 32ndsubject from the Primary Arm has been enrolled. Investigators are not allowed to enroll into the Emergent Arm until one elective case has been performed.
It is anticipated that up to 150 patients will be recruited over a 12 month period (approximately). Patients will be evaluated at the following timepoints: Pre-procedure, Implant, Discharge/30 days, 3 months, 12 months and 24 months.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 150 is above the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →Vascutek Ltd. is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
First submitted after Vascutek Ltd. became part of Terumo Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 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.
The absence of a major adverse event (MAE) at 6-month post procedure.
The primary endpoint is the absence of a major adverse event (MAE) at 6-month post procedure. MAE are defined as follows are will be assessed as composite and individually: Permanent disabling stroke Permanent paraplegia/paraparesis Device-related (Rapidlink) reinterventions All-cause mortality * Device-related mortality (arch graft and/or branch graft) * Procedure-related mortality * Not device or procedure related
Time frame: 6 months post procedure
Technical Success of the Rapidlink portion of the procedure
Technical Success: of the Rapidlink portion of the procedure is a composite endpoint evaluated at 30 days by the implanting physician and is defined as follows: * Successful access to the arterial system * Successful delivery and deployment of the Rapidlink device in the planned location without unplanned vessel coverage * Absence of Rapidlink-related Type I or Type III endoleaks (or resolution by 30 days) as determined by imaging confirmation * Patency of the Rapidlink device (defined as less than 50% stenosis or without the need for re-intervention due to stenosis), * Absence of device deformations requiring unplanned placement of an additional device * Successful withdrawal of the Rapidlink delivery system (without unanticipated corrective action related to the withdrawal)
Time frame: 30 days post-procedure
Clinical Success (Total Arch Repair)
Clinical Success (Total Arch Repair) is defined as: * Absence of lesion-related mortality * Absence of persistent Type I or Type III endoleak\* * Absence of device infection * Absence of aortic thrombosis * Absence of new dissection * Absence of loss of patency (any unanticipated loss of patency of supra-aortic vessels)\*\* * Absence of secondary intervention or conversion to open surgery completed to address a loss of device integrity * Absence of permanent paraplegia/paraparesis, permanent stroke, or laryngeal nerve paralysis that resulted from the initial operation or a secondary intervention to correct the treated supra-aortic vessels connections Clinical Success will be assessed as a composite and all individual elements
Time frame: At discharge/30 days, 6-Months, 12 Months and 24 Months post-procedure
Rate of Aortic or supra-aortic vessel rupture
Rate of Aortic or supra-aortic vessel rupture
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of Stroke of any type, including transient ischemic attacks
Rate of Stroke of any type, including transient ischemic attacks
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of Pseudoaneurysm in the treated segment
Rate of Pseudoaneurysm in the treated segment of the aorta
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Device-related serious adverse events
Rate of Device-related serious adverse events
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of endoleaks
Rate of core laboratory imaging confirmed endoleak of any type
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of migration of the Rapidlink Device
Migration defined as: Movement (caudal and/or cranial) of device of \>10 mm as compared to first post-procedural imaging (e.g., discharge/30-day).
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of Loss of Device (Rapidlink) integrity
Fracture of stent and or disruption of fabric or suture material as confirmed by imaging.
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Patency related observations (e.g., asymptomatic loss of patency, stenosis) of the Rapidlink device
Rate of patency related observations by type, confirmed by imaging
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of Lesion or device-related secondary interventions
Rate of lesion or device-related secondary interventions
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Clinical utility measures
Duration of procedure and Implantation of Device (Hours)
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Clinical utility measures
Volume of Bloodloss and Volume of transfusion or replacement blood products
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Clinical Utility Measures
Length of Duration of hospital stay (days)
Time frame: At discharge/30days, 6 months, 12 months and 24 months post-procedure
Clinical Utility Measures
Duration in Intensive Care Unit (days)
Time frame: At discharge/30days, 6 months, 12 months and 24 months post-procedure
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Nov 2027, 23 months after the start.
Of 44 interventional studies with no phase under Aortic Aneurysm, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 70. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
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