Aortic AneurysmRAPIDNCT07078383
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
A study testing Rapidlink in people with Aortic Aneurysm and Aortic Aneurysm and Dissection, run by Vascutek Ltd. at 21 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases
- What is being tested?
- Rapidlink
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 21 sitesin 5 countries
- Study dates
- 19 Dec 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
Trial locations and contacts
21 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 5 countries
United States15 sites, 15 recruiting
- Not yet recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Clinical Study Coordinator, +1 (303) 724-5020, tien.ngo@cuanschutz.edu
Brett Reece, MD
- Recruiting
Acension Seton Medical Center
Austin, Texas, 78705
Study Coordinator, +1 (512) 324 3434, andrea.stapper@ascension.org
Joshua Grimm
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Study Coordinator, +1 (443) 927-3983, zyriah.robinson@jhmi.edu
Mehrdad Ghoreishi
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02129
Clinical Study Coordinator, 617-724-2610, kdrezek@mgh.harvard.edu
Arminder Jassar, MD
- Not yet recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Principal Investigator, +1 (312) 694-1993, christopher.mehta@nm.org
Christopher Mehta
- Not yet recruiting
UF Health Shands Hospital
Gainesville, Florida, 32608
Jessica Cobb, +1 (352) 273-7837, jessica.cobb@surgery.ufl.edu
Eric Jeng, MD
- Not yet recruiting
Keck Medicine of USC
Los Angeles, California, 90033
Clinical Study Coordinator, +1 (323) 442-5849, morgan.jones@med.usc.edu
Fernando Fleischman, MD
- Not yet recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Clinical Study Coordinator, +1 (310) 248-7484, vanessa.wilson@cshs.org
Pedro Catarino, MD
- Recruiting
Froedhert Hospital
Milwaukee, Wisconsin, 53226
Clinical Research Manager, +1 (414) 955-6994, jzelten@mcw.edu
Jorge Mascaro
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Research Supervisor, +1 (215) 349-8752, elizabeth.durham@pennmedicine.upenn.edu
Nimesh Desai
- Not yet recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15232
Clinical Study Coordinator, +1 (412) 647-7271, valcharka@Upmc.edu
- Recruiting
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
Cardiovascular Research Supervisor, +1 469-814-3278, osniel.gonzalezramos@bswhealth.org
William Brinkman
- Recruiting
Barnes-Jewish Hospital
St Louis, Missouri, 63110
Study Coordinator, +1 (314) 747-1926, aschuck@wustl.edu
Puja Kachroo
- Not yet recruiting
Tampa General Hospital
Tampa, Florida, 33606
Clinical Research Nurse, +1 (813) 844-4914, courtneynicholas@tgh.org
Gundars Katlaps
- Not yet recruiting
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Clinical Study Coordinator, +1 (202) 877-2806, katharine.e.mahoney@medstar.net
Christian Shults
Germany3 sites, 3 recruiting
- Not yet recruiting
University Medical Center Freiburg
Freiburg im Breisgau, 79106
+49 7612 70619600, gabriele.lechner@uniklinik-freiburg.de
Martin Czerny, MD
- Not yet recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Study Coordinator, +49 0407 41057503, j.nogal@uke.de
Jens Brickwedel
- Not yet recruiting
Robert Bosch Hospital
Stuttgart, 70376
Study Coordinator, +49 0711 81014088, yasemin.anguelov@bosch-health-campus.com
Nora Goebel
Austria1 site, 1 recruiting
- Not yet recruiting
University Hospital Vienna
Vienna, 1090
Research Assistant, +431 4040069660, martin.winter@meduniwien.ac.at
Daniel Zimpfer
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Medical Center
Nijmegen, Radboud
Principal Investigator, +31 06 41459041, foeke.nauta@radboudumc.nl
Foeke Nauta
United Kingdom1 site, 1 recruiting
- Not yet recruiting
St Bartholomew's Hospital
London, EC1A 7BE
Clinical Trial Coordinator, +44 7762 804727, vanna.navales@nhs.net
Aung Ye Oo, MD
About this study
Official title: Evaluation of the Rapidlink Device for Use in the Repair or Replacement of the Supra-Aortic Vessels During an Open Surgical Procedure of the Thoracic Aorta
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases, Aneurysm of Aorta, Thoracic, Aneurysmal Disease, Aorta, Thoracic Pathologies
- Being tested
- Rapidlink
- Keywords
- Vascular Prosthesis, Replacement or bypass of disease vessels, aneurysmal disease, Aortic branch vessels, Open aortic arch repair, aneurysm, dissection, Supra-aortic Vessels, Frozen Elephant Trunk, Left Subclavian Artery
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection, Aortic Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapidlinkDevice
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 group | Role | What they receive |
|---|---|---|
| Rapidlink Device | Experimental | Not described Receives: Device: Rapidlink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post procedure
Secondary outcomes (15)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Clinical utility measures
Duration of procedure and Implantation of Device (Hours)
Measured: 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
Measured: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Clinical Utility Measures
Length of Duration of hospital stay (days)
Measured: At discharge/30days, 6 months, 12 months and 24 months post-procedure
Clinical Utility Measures
Duration in Intensive Care Unit (days)
Measured: At discharge/30days, 6 months, 12 months and 24 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start19 Dec 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078383
- Sponsor's protocol ID
- RAPID-001
- Acronym
- RAPID
- Status last verified
- Jul 2026
- First submitted
- 19 Jun 2025
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rapidlink Device for Use in the Repair or Replacement of the Supra-Aortic Vessels During an Open Surgical Procedure of the Thoracic Aorta
- ClinicalTrials.gov ID
- NCT07078383
- Acronym / sponsor ID
- RAPID / RAPID-001
- Conditions
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases, Aneurysm of Aorta, Thoracic, Aneurysmal Disease, Aorta, Thoracic Pathologies
- Keywords
- Vascular Prosthesis, Replacement or bypass of disease vessels, aneurysmal disease, Aortic branch vessels, Open aortic arch repair, aneurysm, dissection, Supra-aortic Vessels
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapidlink Device | Experimental | Device: Rapidlink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapidlinkThe 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. | Device | Rapidlink Device |
Primary outcome
The absence of a major adverse event (MAE) at 6-month post procedure.
Time frame: 6 months 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
15 secondary outcomes
Technical Success of the Rapidlink portion of the procedure
Time frame: 30 days post-procedure
Clinical Success (Total Arch Repair)
Time frame: At discharge/30 days, 6-Months, 12 Months and 24 Months post-procedure
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
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of Pseudoaneurysm in the treated segment
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Device-related serious adverse events
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of endoleaks
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of migration of the Rapidlink Device
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Rate of Loss of Device (Rapidlink) integrity
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
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
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
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Clinical utility measures
Time frame: At discharge/30 days, 6-months, 12 months and 24 months post-procedure
Clinical Utility Measures
Time frame: At discharge/30days, 6 months, 12 months and 24 months post-procedure
Clinical Utility Measures
Time frame: At discharge/30days, 6 months, 12 months and 24 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapidlink in people with Aortic Aneurysm and Aortic Aneurysm and Dissection, run by Vascutek Ltd. at 21 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Germany, Austria, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Macluskie (+441413430333, s.macluskie@terumoaortic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absence of a major adverse event (MAE) at 6-month post procedure. (time frame: 6 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.